NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full...

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NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the PDF file, and open with a PDF reader. Cancer trials ordered by disease area: Brain (pdf) Breast (pdf) Gastrointestinal (pdf) Genitourinary (pdf) Gynecological (pdf) Head and Neck (pdf) Leukemia (pdf) Lymphoma (pdf) Myeloma (pdf) Sarcoma (pdf) Skin (Mainly Melanoma) (pdf) Thoracic (pdf) Adolescent and Young Adult (AYA) (pdf) This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find-a-study/

Transcript of NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full...

Page 1: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the PDF file, and open with a PDF reader.

Cancer trials ordered by disease area:

• Brain (pdf)

• Breast (pdf)

• Gastrointestinal (pdf)

• Genitourinary (pdf)

• Gynecological (pdf)

• Head and Neck (pdf)

• Leukemia (pdf)

• Lymphoma (pdf)

• Myeloma (pdf)

• Sarcoma (pdf)

• Skin (Mainly Melanoma) (pdf)

• Thoracic (pdf)

• Adolescent and Young Adult (AYA) (pdf)

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find-a-study/

Page 2: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Cross-disease trials:

Brai

nCraniopharyngioma A071601

High Grade (Grade IV) Giloma - Glioblastoma

(GBM)

Newly diagnosed NRG-BN001

Recurrent EAF151

Low and Intermediate Grade (Grade II and

III) Glioma

1p/19q Co-deletion, Anaplastic or low grade

N0577 (CODEL)

IDH Mutant, Low and intermediate grade NRG-BN005

Meningioma

Gross totally resected, Grade II NRG-BN003

SMO/AKT/NF2 mutated, Progressive A071401

Metastases to Brain

5-15 brain metastases CCTG CE.7

Presence of alteration in NTRK, ROS1, CDK or PI3K

pathwayA071701

3 or fewer unresected brain metastases post-

resectionA071801

EAY131 (MATCH) S1609 (DART)

NCTN Brain Cancer Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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NCTN Brain Cancer Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A071401 IIPhase II Trial of SMO/ AKT/ NF2 Inhibitors in Progressive Meningiomas with SMO/ AKT/ NF2 Mutations

A071601 II Phase II Trial of BRAF/MEK Inhibitors in Papillary CraniopharyngiomasA071701 II Genomically‐Guided Treatment Trial in Brain Metastases

A071801 IIIPhase III Trial of Post‐Surgical Single Fraction Stereotactic Radiosurgery (SRS) Compared with Fractionated SRS (FSRS) for Resected Metastatic Brain Disease

CCTG CE.7 IIIA Phase III Trial of Stereotactic Radiosurgery Compared with Whole Brain Radiotherapy (WBRT) for 5‐15 Brain Metastases

EAF151 IIChange in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma

N0577 III

N0577 (CODEL): Phase III Intergroup Study of Radiotherapy with Concomitant and Adjuvant Temozolomide versus Radiotherapy with Adjuvant PCV Chemotherapy in Patients with 1p/19q Co‐deleted Anaplastic Glioma or Low Grade Glioma

NRG‐BN001 II

Randomized Phase II Trial of Hypofractionated Dose‐Escalated Photon IMRT or Proton Beam Therapy Versus Conventional Photon Irradiation with Concomitant and Adjuvant Temozolomide in Patients with Newly Diagnosed Glioblastoma

NRG‐BN003 IIIPhase III Trial of Observation Versus Irradiation for a Gross Totally Resected Grade II Meningioma

NRG‐BN005 IIA Phase II Randomized Trial of Proton Vs. Photon Therapy (IMRT) for Cognitive Preservation in Patients with IDH Mutant, Low to Intermediate Grade Gliomas

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

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NCTN Breast Cancer Trials Portfolio (Open as of 5/15/2020)

Post‐NeoadjuvantNeoadjuvant Adjuvant Metastatic

Surgery (Intra‐Operative)

NRG‐BR005Any HR/HER2 status

NSABP‐B‐51Any HR/HER2 status

A011202Any HR/HER2 status

Residual Disease

EA1131TNBC

Stage II/III

S1418TNBC

Stage II/III

A011401 (BWEL)HER2‐

Stage II/III

A011502 (ABC)HER2‐

Stage II/III

NRG‐BR003TNBC

EAI142HR+/HER2‐

[18F] Fluoroestradiol PET study

Legend by Subtype Status

Green = TNBC Blue = HER2‐(Any HR status)

Orange = HER2+(Any HR status)

Purple = HR+ and HER2‐

White = Any HR/HER2 

status

NRG‐BR002Any HR/HER2 status

Female only; No brain mets

EAY131(MATCH)

S1609(DART)

Pink = Cross‐disease trials

CCTG MA.39HR+/HER2‐

Low risk; Node positive

S1706Any HR/HER2 status

Inflammatory; No mets

NRG‐BR004HER2+1st line

Some brain mets allowed

EA1181HER2+

Stage II and IIIa

Yellow = HR+ (Any HER2 status)

EA1183 (FEATURE)HR+

Bone‐dominant (BD) or bone‐only (BO) disease

Click on trial number to go to the associated ClinicalTrials.gov webpage, to view the protocol title and study information.

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NCTN Breast Cancer Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A011202 IIIA Randomized Phase III Trial Comparing Axillary Lymph Node Dissection to Axillary Radiation in Breast Cancer Patients (cT1‐3 N1) Who Have Positive Sentinel Lymph Node Disease After Neoadjuvant Chemotherapy

A011401 IIIRandomized Phase III Trial Evaluating the Role of Weight Loss in Adjuvant Treatment of Overweight and Obese Women with Early Breast Cancer

A011502 IIIA Randomized Phase III Double Blinded Placebo Controlled Trial of Aspirin as Adjuvant Therapy for HER2 Negative Breast Cancer: The ABC Trial

CCTG MA.39 III Tailor RT: A Randomized Trial of Regional Radiotherapy in Biomarker Low Risk Node Positive Breast Cancer

EA1131 IIIA Randomized Phase III Post‐Operative Trial of Platinum Based Chemotherapy Vs. Capecitabine in Patients with Residual Triple‐Negative Basal‐Like Breast Cancer following Neoadjuvant Chemotherapy

EA1181 II

EA1181 (CompassHER2‐pCR): Preoperative THP and Postoperative HP in Patients Who Achieve a Pathologic Complete ResponsePart 1 Component of: The CompassHER2 Trials (COMprehensive Use of Pathologic Response ASSessment to Optimize Therapy in HER2‐Positive Breast Cancer)

EA1183 II FDG PET to Assess Therapeutic Response in Patients with Bone‐Dominant Metastatic Breast Cancer, FEATURE

EAI142 II [18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients with Newly Diagnosed Metastatic Breast Cancer

NRG‐BR002 II/IIIA Phase IIR/III Trial of  Standard of Care Therapy with or Without Stereotactic Body Radiotherapy (SBRT) and/or Surgical Ablation for Newly Oligometastatic Breast Cancer

NRG‐BR003 IIIA Randomized Phase III Trial of Adjuvant Therapy Comparing Doxorubicin Plus Cyclophosphamide Followed by Weekly Paclitaxel with or Without Carboplatin for Node‐Positive or High‐Risk Node‐Negative Triple‐Negative Invasive Breast Cancer

NRG‐BR004 IIIA Randomized, Double‐Blind, Phase III Trial of Paclitaxel/Trastuzumab/Pertuzumab with Atezolizumab or Placebo in First‐Line HER2‐Positive Metastatic Breast Cancer

NRG‐BR005 IIA Phase II Trial Assessing the Accuracy of Tumor Bed Biopsies in Predicting Pathologic Response in Patients with Clinical/Radiologic Complete Response After Neoadjuvant Chemotherapy in Order to Explore the Feasibility of Breast Conserving Treatment Without Surgery

NSABP‐B‐51 III

A Randomized Phase III Clinical Trial Evaluating Post‐Mastectomy Chestwall and Regional Nodal XRT and Post‐Lumpectomy Regional Nodal XRT in Patients with Positive Axillary Nodes Before Neoadjuvant Chemotherapy Who Convert to Pathologically Negative Axillary Nodes After Neoadjuvant Chemotherapy

S1418 IIIA Randomized, Phase III Trial to Evaluate the Efficacy and Safety of MK‐3475 (Pembrolizumab) as Adjuvant Therapy for Triple Receptor‐Negative Breast Cancer with >/= 1 CM Residual Invasive Cancer or Positive Lymph Nodes (ypN+) after Neoadjuvant Chemotherapy

S1706 IIA Phase II Randomized Trial of Olaparib (NSC‐747856) Administered Concurrently with Radiotherapy Versus Radiotherapy Alone for Inflammatory Breast Cancer

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 6: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Gast

roin

test

inal

Gastro-esophageal

cancer

Adenocarcinoma

Newly diagnosed,

locoregional

Peri-operative immuno-therapy

EA2174

Oligometastatic, HER2 negative

Consolidate Radiotherapy EA2183

Adenocarcinoma or Squamous cell

carcinoma

No T4b, no metastatic

disease

Proton vs. Photon

NRG-GI006

Adedo-carcinoma

of the small intestine

Metastatic or locally advanced RAM/PAC vs. FOLFIRI S1922

Adeno-carcinoma

of the colon

Deficient DNA Mismatch Repair

Stage III adjuvant immunotherapy

A021502 (ATOMIC)

Newly diagnosed, Post-resection, Stage IIA

Adjuvant chemotherapy vs. Active surveillance

NRG-GI005 (COBRA)

Colorectal cancer

HER-2 Amplification Adenocarcinoma

Advanced/ Metastatic -TP vs. CETIRI S1613

Deficient DNA Mismatch Repair

Stage IV - chemo immunotherapy

NRG-GI004 (COMMIT)

No dMMR or MSI-H disease

Advanced/Metastatic -Vitamin D3

A021703 (SOLARIS)

Adeno-carcinoma

of the rectum

Stage II-III Low rectum, high risk

Total neoadjuvant therapy + radiation

sensitization

NRG-GI002 (TNT)

Anal cancer

Stage T1-2N0M0, Tumor <=4cm

Standard vs. De-intensified

chemoradiation

EA2182 (DECREASE)

Stage II (T3N0 only), IIIA or IIIB Adjuvant Nivolumab EA2165

Billiary tract cancers

Metastatic or Unresectable

Newly diagnosed

Gem/Cisplatin with vs. without Nab-

PaclitaxelS1815

ProgressedPevonedistat with vs.

without Carboplatin+Paclitaxel

EA2187

Hepatocellular carcinomaProton vs. Photon NRG-GI003

Sorafenib with vs. without SBRT RTOG-1112

NCTN Gastrointestinal Cancer Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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Cross-disease trials:

Gast

roin

test

inal Gastroenteropancreatic

Neuroendocrine Tumors (GEP NETs)

Locally advanced and unresectable or metastatic;

Grade 3 onlyEA2142

Locally advanced/unresectable or

metastatic disease; Progressed on Everolimus

Pancreatic Neuroendocrine Tumors

(PNETs)

Locally advanced/unresectable or

metastatic disease; Progressed on Everolimus

A021602 (CABINET)

EAY131 (MATCH) S1609 (DART)

NCTN Gastrointestinal Cancer Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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NCTN Gastrointestinal Cancer Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A021502 III

Randomized Trial of Standard Chemotherapy Alone or Combined with Atezolizumab as Adjuvant Therapy for Patients with Stage III Colon Cancer and Deficient DNA Mismatch Repair

A021602 III

Randomized, Double‐Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

A021703 IIIRandomized Double‐Blind Phase III Trial of Vitamin D3 Supplementation in Patients with Previously Untreated Metastatic Colorectal Cancer (SOLARIS)

EA2142 II

Randomized Phase II Study of Platinum and Etoposide Versus Temozolomide and Capecitabine in Patients with Advanced G3 Non‐Small Cell Gastroenteropancreatic  Neuroendocrine Carcinomas

EA2165 IIA Randomized Phase II Study of Nivolumab After Combined Modality Therapy (CMT) in High Risk Anal Cancer

EA2174 II/IIIA Phase II/III Study of Peri‐Operative Nivolumab and Ipilimumab in Patients with Locoregional Esophageal and Gastroesophageal Junction Adenocarcinoma

EA2182 IIA Randomized Phase II Study of De‐Intensified ChemoRadiation for Early‐Stage Anal Squamous Cell Carcinoma (DECREASE)

EA2183 IIIA Phase III Study of Consolidative Radiotherapy in Patients with Oligometastatic HER2 Negative Esophageal and Gastric Adenocarcinoma (EGA)

EA2187 IIA Phase 2 Study of Pevonedistat in Combination with Carboplatin and Paclitaxel in Advanced Intrahepatic Cholangiocarcinoma

NRG‐GI002 IIA Phase II Clinical Trial Platform of Sensitization Utilizing Total Neoadjuvant Therapy (TNT) in Rectal Cancer

NRG‐GI003 III A Phase III Randomized Trial of Protons Versus Photons for Hepatocellular Carcinoma

NRG‐GI004 III

Colorectal Cancer Metastatic dMMR Immuno‐Therapy (COMMIT) Study: A Randomized Phase III Study of mFOLFOX6/Bevacizumab Combination Chemotherapy with or Without Atezolizumab or Atezolizumab Monotherapy in the First‐Line Treatment of Patients with Deficient DNA Mismatch Repair (dMMR) Metastatic Colorectal Cancer

NRG‐GI005 II/IIIPhase II/III Study of Circulating Tumor DNA as a Predictive Biomarker in Adjuvant Chemotherapy in Patients with Stage IIA Colon Cancer (COBRA)

NRG‐GI006 IIIPhase III Randomized Trial of Proton Beam Therapy (PBT) Versus Intensity Modulated Photon Radiotherapy (IMRT) for the Treatment of Esophageal Cancer

RTOG‐1112 IIIRandomized Phase III Study of Sorafenib Versus Stereotactic Body Radiation Therapy Followed by Sorafenib in Hepatocellular Carcinoma

S1613 II

A Randomized Phase II Study of Trastuzumab and Pertuzumab (TP) Compared to Cetuximab and Irinotecan (CETIRI) in Advanced/Metastatic Colorectal Cancer (MCRC) with HER‐2 Amplification

S1815 IIIA Phase III Randomized Trial of Gemcitabine, Cisplatin, and Nab‐Paclitaxel Versus Gemcitabine and Cisplatin in Newly Diagnosed, Advanced Biliary Tract Cancers

S1922 IIRandomized Phase II Selection Study of Ramucirumab and Paclitaxel Versus FOLFIRI in Refractory Small Bowel Adenocarcinoma

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 9: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Geni

tour

inar

y

Prostate cancer

Newly diagnosed, Surgical Tx indicated

Advanced imaging study (mpMRI) EA8171

Localized, Previously untreated, Intermediate risk

RT: SBRT (5 fractions) vs. IMRT (28 fractions) NRG-GU005

Previously untreated, High risk, Non-metastatic

ADT + Radiation with vs. without Niraparib NRG-GU007

Previously untreated, Metastatic

SST with vs. without definitive tx of primary tumor S1802

Post Prostatectomy, High risk

Radiation with vs. without Docetaxel NRG-GU002

Post Prostatectomy, High PSA

Salvage RT with Placebo vs. Apalutamide

NRG-GU006 (BALANCE)

Post Prostatectomy, Node positive, M0 disease

Standard RT + Hormonal therapy with vs. without

Anti-AndrogensNRG-GU008

Metastatic, Castration-resistant

ADT + Abiraterone with vs. without Cabazitaxel

EA8153 (CHAARTED2)

Renal cell carcinoma

Newly diagnosed, High risk, M0 EA8143 (PROSPER RCC)

Metastatic, Untreated A031704 (PDIGREE)

TFE/translocation; Unresectable or metastatic AREN1721

At least two untreated bone metastases A031801 (RadiCal)

Urothelial tract/Bladde

r cancer

High grade, Non-Muscle invasive

BCG-Naive S1602

BCG-Unresponsive A031803

Muscle invasive

Localized S1806

Post bladder resection

A031501 (AMBASSADOR)

Newly diagnosed, T2-4a,N0/x,M0 A031701Rare GU

cancersMetastatic

disease A031702

Penile squamous carcinoma

Any T, N1-3, M0 EA8134 (InPACT)

Germ cell cancer

Progressive or Recurrent

AYA Study (Age>=14,

Male)

A031102 (TIGER)

NCTN Genitourinary Cancer Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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EAY131 (MATCH) S1609 (DART)

NCTN Genitourinary Cancer Trials Portfolio (Open as of 5/15/2020) Each box below includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

Cross-disease trials:

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NCTN Genitourinary Cancer Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A031102 III

A Randomized Phase III Trial Comparing Conventional‐Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High‐Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High‐Dose Carboplatin and Etoposide (TI‐CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

A031501 IIIPhase III Randomized Adjuvant study of MK‐3475 (Pembrolizumab) in muScle invaSive and locAlly aDvanced urOthelial caRcinoma (AMBASSADOR) Versus Observation

A031701 II

A Phase II Study of Dose‐Dense Gemcitabine Plus Cisplatin (ddGC) in Patients with Muscle‐Invasive Bladder Cancer with Bladder Preservation for Those Patients Whose Tumors Harbor Deleterious DNA Damage Response (DDR) Gene Alterations

A031702 IIPhase II Study of Cabozantinib in Combination with Nivolumab and Ipilimumab in Rare Genitourinary Tumors

A031704 IIIPD‐Inhibitor (Nivolumab) and Ipilimumab Followed by Nivolumab Vs. VEGF TKI Cabozantinib with Nivolumab: A Phase III Trial in Metastatic Untreated REnal Cell CancEr [PDIGREE]

A031801 IIA Phase II Randomized Trial of Radium‐223 Dichloride and Cabozantinib in Patients with Advanced Renal Cell Carcinoma with Bone Metastasis (RadiCal)

A031803 IIPhase II Trial of Intravesical Gemcitabine and MK‐3475 (Pembrolizumab) in the Treatment of Patients with BCG‐Unresponsive Non‐Muscle Invasive Bladder Cancer

AREN1721 II

A Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

EA8134 III InPACT‐ International Penile Advanced Cancer Trial (International Rare Cancers Initiative Study)

EA8143 IIIA Phase 3 RandOmized Study Comparing PERioperative Nivolumab Vs. Observation in Patients with Localized Renal Cell Carcinoma Undergoing Nephrectomy (PROSPER RCC)

EA8153 IICabazitaxel with Abiraterone Versus Abiraterone Alone Randomized Trial for Extensive Disease Following Docetaxel: The CHAARTED2 Trial

EA8171 IIMultiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly‐Diagnosed Prostate Cancer

NRG‐GU002 II/IIIPhase II‐III Trial of Adjuvant Radiotherapy and Androgen Deprivation Following Radical Prostatectomy with or Without Adjuvant Docetaxel

NRG‐GU005 IIIPhase III IGRT and SBRT Vs IGRT and Hypofractionated IMRT for Localized Intermediate Risk Prostate Cancer

NRG‐GU006 IIA Phase II, Double‐Blinded, Placebo‐Controlled Randomized Trial of Salvage Radiotherapy with or Without Enhanced Anti‐Androgen Therapy with Apalutamide in Recurrent Prostate Cancer

NRG‐GU007 IIRandomized Phase II Trial of Niraparib with Standard Combination Radiotherapy and Androgen Deprivation Therapy (ADT) in High Risk Prostate Cancer (with Initial Phase I)

NRG‐GU008 III

Randomized Phase III Trial Incorporating Abiraterone Acetate with Prednisone and Apalutamide and Advanced Imaging Into Salvage Treatment for Patients with Node‐Positive Prostate Cancer After Radical Prostatectomy

S1602 III

A Phase III Randomized Trial to Evaluate the Influence of BCG Strain Differences and T Cell Priming with Intradermal BCG Before Intravesical Therapy for BCG‐Naive High‐Grade Non‐Muscle Invasive Bladder Cancer

S1802 III

Phase III Randomized Trial of Standard Systemic Therapy (SST) Versus Standard Systemic Therapy Plus Definitive Treatment (Surgery or Radiation) of the Primary Tumor in Metastatic Prostate Cancer

S1806 IIIPhase III Randomized Trial of Concurrent Chemoradiotherapy with or Without Atezolizumab in Localized Muscle Invasive Bladder Cancer

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 12: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Gyne

colo

gic

Ovarian cancer

Epithelial

Newly diagnosed Low grade serous NRG-GY019

Recurrent

Platinum sensitive

All HGS/EOC, and others w

BRCA mutation

NRG-GY021

Platinum resistant

All histology NRG-GY009

HGSOC NRG-GY005 (COCOS)

Clear cell NRG-GY016

Endometrioid NRG-GY014Non-

Epithelial Stromal, Newly diagnosed GOG-0264

Germ cellLow-standard risk AGCT1531

Intermediate and poor risk metastatic AGCT1532

Cervical cancer

(sq, adeno, adeno sq)

Organ confined, High risk

GOG-0263

RTOG-0724

Newly diagnosed, Locally advanced

NRG-GY017

NRG-GY006

Vaginal cancer Newly diagnosed,Locally advanced

Uterine cancer

Newly diagnosed, Stage I/II

High intermediate risk, Deficient Mismatch

Repair (dMMR)NRG-GY020

First recurrence, Local only GOG-0238

Stage III/IV or recurrent NRG-GY018

RecurrentAny histology NRG-GY012

Endometrioid NRG-GY014Trophoblastic

tumors Recurrent S1609 (DART)

NCTN Gynecologic Cancer Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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EAY131 (MATCH) S1609 (DART)

NCTN Gynecologic Cancer Trials Portfolio (Open as of 5/15/2020) Each box below includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

Cross-disease trials:

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NCTN Gynecologic Cancer  Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

AGCT1531 IIIA Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

AGCT1532 IIIA Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor‐Risk Germ Cell Tumors

GOG‐0238 IIA Randomized Trial of Pelvic Irradiation with or Without Concurrent Weekly Cisplatin in Patients with Pelvic‐Only Recurrence of Carcinoma of the Uterine Corpus

GOG‐0263 III

Randomized Phase III Clinical Trial of Adjuvant Radiation Versus Chemoradiation in Intermediate Risk, Stage I/IIA Cervical Cancer Treated with Initial Radical Hysterectomy and Pelvic Lymphadenectomy (NCT #01101451)

GOG‐0264 II

A Randomized Phase II Trial of Paclitaxel and Carboplatin vs. Bleomycin, Etoposide, and Cisplatin for Newly Diagnosed Advanced Stage and Recurrent Chemonaive Sex Cord‐Stromal Tumors of the Ovary

NRG‐GY005 II/III

A Randomized Phase II/III Study of the Combination of Cediranib and Olaparib Compared to Cediranib or Olaparib Alone, or Standard of Care Chemotherapy in Women with Recurrent Platinum‐Resistant or ‐Refractory Ovarian, Fallopian Tube, or Primary Peritoneal Cancer (COCOS)

NRG‐GY006 II

A Randomized Phase II Trial of Radiation Therapy and Cisplatin Alone or in Combination with Intravenous Triapine in Women with Newly Diagnosed Bulky Stage IB2, Stage II, IIIB, or IVA Cancer of the Uterine Cervix or Stage II‐IVA Vaginal Cancer

NRG‐GY009 II/III

A Randomized, Phase II/III Study of Pegylated Liposomal Doxorubicin and CTEP‐Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab and CTEP‐Supplied Atezolizumab Versus Pegylated Liposomal Doxorubicin/Bevacizumab in Platinum Resistant Ovarian Cancer

NRG‐GY012 II

A Randomized Phase II Study Comparing Single‐Agent Olaparib, Single Agent Cediranib, and the Combination of Cediranib/Olaparib in Women with Recurrent, Persistent or Metastatic Endometrial Cancer

NRG‐GY014 II

A Phase II Study of Tazemetostat (EPZ‐6438) (IND # 138671) in Recurrent or Persistent Endometrioid or Clear Cell Carcinoma of the Ovary, and Recurrent or Persistent Endometrioid Endometrial Adenocarcinoma

NRG‐GY016 IIA Phase II Study of MK‐3475 (Pembrolizumab) (NSC #776864) + Epacadostat (NSC #766086) in Recurrent Clear Cell Carcinoma of the Ovary

NRG‐GY017 IAnti PD‐L1 (Atezolizumab) as an Immune Primer and Concurrently with Extended Field Chemoradiotherapy for Node Positive Locally Advanced Cervical Cancer

NRG‐GY018 III

A Phase III Randomized, Placebo‐Controlled Study of Pembrolizumab (MK‐3475, NSC #776864) in Addition to Paclitaxel and Carboplatin for Measurable Stage III or IVA, Stage IVB or Recurrent Endometrial Cancer

NRG‐GY019 III

A Randomized Phase III, Two‐Arm Trial of Paclitaxel/Carboplatin/Maintenance Letrozole Versus Letrozole Monotherapy in Patients with Stage II‐IV, Primary Low‐Grade Serous Carcinoma of the Ovary or Peritoneum

NRG‐GY020 III

A Phase III Randomized Trial of Radiation +/‐ MK‐3475 (Pembrolizumab) for Newly Diagnosed Early Stage High Intermediate Risk Mismatch Repair Deficient (dMMR) Endometrioid Endometrial Cancer

NRG‐GY021 IIA Phase II Randomized Trial of Olaparib Versus Olaparib Plus Tremelimumab in Platinum‐Sensitive Recurrent Ovarian Cancer

RTOG‐0724 III

Phase III Randomized Study of Concurrent Chemotherapy and Pelvic Radiation Therapy with or without Adjuvant Chemotherapy in High‐Risk Patients with Early‐Stage Cervical Carcinoma Following Radical Hysterectomy

S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare TumorsEAY131 II Molecular Analysis for Therapy Choice (MATCH)

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

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Head

and

Nec

k

Head and neck squamous cell

carcinoma, NOS

Untreated, Early stage, P16-positive NRG-HN005

Untreated, Locally advanced, Intermediate risk, P16-positive EA3161

Untreated, unresected disease, Stage III-IVB (M0),

Contraindication to CisplatinNRG-HN004

Stage T3 or T4a with N0 or N1-3, Surgically resectable EA3163

Post surgical resection, Pathologic stage III or IVA (M0)

(p53 status required)EA3132

Post surgical resection, High risk pathologic features, Pathologic stage III or IV (M0) (EGFR status required; For Oropharynx: p16

negative)

RTOG-1216

Nasopharyngeal carcinoma

Detectable pretreatment plasma EBV DNA, Stage II-IVB disease

with no evidence of distant metastasis

NRG-HN001

Salivary gland cancer

Post surgical resection, pT3-4N1-3M0 or pT1-2N0M0 with positive

marginRTOG-1008

NCTN Head and Neck Cancer Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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EAY131 (MATCH) S1609 (DART)

NCTN Head and Neck Cancer Trials Portfolio (Open as of 5/15/2020) Each box below includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

Cross-disease trials:

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NCTN Head and Neck Cancer Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

EA3132 IIPhase II Randomized Trial of Radiotherapy with or Without Cisplatin for Surgically Resected Squamous Cell Carcinoma of the Head and Neck (SCCHN) with TP53 Sequencing

EA3161 II/IIIA Phase II/III Randomized Study of Maintenance Nivolumab Versus Observation in Patients with Locally Advanced, Intermediate Risk HPV Positive OPCA

EA3163 II

Phase II Randomized Trial of Neo‐Adjuvant Chemotherapy Followed by Surgery and Post‐Operative Radiation Versus Surgery and Post‐Operative Radiation for Organ Preservation of T3 and T4a Nasal and Paranasal Sinus Squamous Cell Carcinoma (NPNSCC)

NRG‐HN001 II/IIIRandomized Phase II and Phase III Studies of Individualized Treatment for Nasopharyngeal Carcinoma Based on Biomarker Epstein Barr Virus (EBV) Deoxyribonucleic Acid (DNA)

NRG‐HN004 II/III

Randomized Phase II/III Trial of Radiotherapy with Concurrent MEDI4736 (Durvalumab) Vs. Radiotherapy with Concurrent Cetuximab in Patients with Stage III‐IVB Head and Neck Cancer with a Contraindication to Cisplatin

NRG‐HN005 II/IIIA Randomized Phase II/III Trial of De‐Intensified Radiation Therapy for Patients with Early‐Stage, P16‐Positive, Non‐Smoking Associated Oropharyngeal Cancer

RTOG‐1008 IIA Randomized Phase II / Phase III Study of Adjuvant Concurrent Radiation and Chemotherapy Versus Radiation Alone in Resected High‐Risk Malignant Salivary Gland Tumors

RTOG‐1216 II/III

Randomized Phase II/III Trial of Surgery and Postoperative Radiation Delivered with Concurrent Cisplatin Versus Docetaxel Versus Docetaxel and Cetuximab for High‐Risk Squamous Cell Cancer of the Head and Neck

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 18: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Leuk

emia

Acute lymphoblastic leukemia (ALL)

Newly diagnosed, CD22-positive, Ph

negative

Age ≥ 18 years and < 40 years A041501

Ph negative: Newly diagnosed;

Ph positive or Ph-like: Newly diagnosed or relapsed/refractory

Age ≥ 65 years S1318

Relapsed or refractory Age ≥ 18 years EA9152

Acute myeloid leukemia (AML)

Newly diagnosed AML or Myelodysplastic

syndrome with excess blasts-2 (MDS-EB-2)

Age ≥ 60 years S1612

Newly diagnosed, no activating FLT3

mutationAge ≥ 60 years A041701

Precursor B-lymphoblastic leukemia (B-

precursor ALL)

Ph negative , CD22-positive

Age ≥ 60 years, Newly

diagnosed A041703Age ≥ 18 years,

Relapsed or refractory

Chronic lymphocytic

leukemia (CLL)

Untreated disease, meet indication for

treatment

Age ≥ 18 years and < 70 years EA9161

Age ≥ 70 years A041702

Chronic myelogenous

leukemia (CML)

Philadelphia chromosome positive Age ≥ 18 years

S1712

EA9171

NCTN Leukemia Trials Portfolio (Open as of 5/15/2020)Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

Page 19: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

NCTN Leukemia Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A041501 III

A Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti‐CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18‐39 Years) with Newly Diagnosed Precursor B‐Cell ALL

A041701 II/IIIA Randomized Phase II/III Study of Conventional Chemotherapy +/‐ Uproleselan (GMI‐1271) in Older Adults with Acute Myeloid Leukemia Receiving Intensive Induction Chemotherapy

A041702 III

A Randomized Phase III Study of Ibrutinib Plus Obinutuzumab Versus Ibrutinib Plus Venetoclax and Obinutuzumab in Untreated Older Patients (>/= 70 Years of Age) with Chronic Lymphocytic Leukemia (CLL)

A041703 II

A Phase II Study of Inotuzumab Ozogamicin Followed by Blinatumomab for Ph‐Negative, CD22‐Positive B‐Lineage Acute Lymphoblastic Leukemia in Newly Diagnosed Older Adults or Adults with Relapsed or Refractory Disease

EA9152 I/IIA Phase IB/II Study of Venetoclax (ABT‐199) in Combination with Liposomal Vincristine in Patients with Relapsed or Refractory T‐Cell or B‐Cell Acute Lymphoblastic Leukemia

EA9161 IIIA Randomized Phase III Study of the Addition of Venetoclax to Ibrutinib and Obinutuzumab Versus Ibrutinib and Obinutuzumab in Untreated Younger Patients with Chronic Lymphocytic Leukemia (CLL)

EA9171 IIPhase II Study of Adding the Anti‐PD‐1 Pembrolizumab to Tyrosine Kinase Inhibitors in Patients with Chronic Myeloid Leukemia and Persistently Detectable Minimal Residual Disease

S1318 II

A Phase II Study of Blinatumomab (NSC‐765986) and POMP (Prednisone, Vincristine, Methotrexate, 6‐Mercaptopurine) for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia‐Chromosome Negative (Ph‐) Acute Lymphoblastic Leukemia (ALL) and of Dasatinib (NSC‐732517), Prednisone and Blinatumomab for Patients >/= 65 Years of Age with Newly Diagnosed Philadelphia‐Chromosome Positive (Ph+) ALL, Relapsed/Refractory Philadelphia‐Chromosome Positive (Ph+) ALL, and Philadelphia‐Chromosome‐Like Signature (Ph‐Like) ALL (Newly Diagnosed or Relapsed/Refractory) with Known or Presumed Activating Dasatinib‐Sensitive Mutations or Kinase Fusions (DSMKF)

S1612 II/III

A Randomized Phase II/III Trial of "Novel Therapeutics" Versus Azacitidine in Newly Diagnosed Patients with Acute Myeloid Leukemia (AML) or High‐Risk Myelodysplastic Syndrome (MDS), Age 60 or Older (LEAP: Less‐Intense AML Platform Trial)

S1712 IIA Randomized Phase II Study of Ruxolitinib (NSC‐752295) in Combination with BCR‐ABL Tyrosine Kinase Inhibitors in Chronic Myeloid Leukemia (CML) Patients with Molecular Evidence of Disease

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 20: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Cross-disease solid tumor trial:

Lym

phom

aDiffuse large B-cell

lymphoma

Relapsed or Refractory A051301

Newly diagnosed, MYC/BCL2 Double-Hit or Double-Expressing

A051701

Follicular lymphoma Relapsed or Refractory S1608

Mantle cell lymphoma

Untreated, with cyclin D1 (BCL1) expression

and/or t(11;14)EA4181

Evaluation of transplant and minimal residual

disease post initial induction therapy

EA4151

Classical Hodgkin lymphoma

Newly diagnosed, Untreated, Stage III/IV S1826

Relapsed or Refractory E4412

EAY131 (MATCH)

NCTN Lymphoma Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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NCTN Lymphoma Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A051301 III

A Randomized Double‐Blind Phase III Study of Ibrutinib During and Following Autologous Stem Cell Transplantation Versus Placebo in Patients with Relapsed or Refractory Diffuse Large B‐cell Lymphoma of the Activated B‐cell Subtype

A051701 II/IIIRandomized Phase II/III Study of Venetoclax (ABT199) Plus Chemoimmunotherapy for MYC/BCL2 Double‐Hit and Double Expressing Lymphomas

E4412 I/II

A Phase I Study with an Expansion Cohort/Randomized Phase II Study of the Combinations of Ipilimumab, Nivolumab and Brentuximab Vedotin in Patients with Relapsed/Refractory Hodgkin Lymphoma

EA4151 III

A Randomized Phase III Trial of Consolidation with Autologous Hematopoietic Cell Transplantation Followed by Maintenance Rituximab vs Maintenance Rituximab Alone for Patients with Mantle Cell Lymphoma in Minimal Residual Disease‐Negative First Complete Remission

EA4181 II

A Randomized 3‐Arm Phase II Study Comparing 1.) Bendamustine, Rituximab and High Dose Cytarabine (BR/CR) 2.) Bendamustine, Rituximab, High Dose Cytarabine and Acalabrutinib (BR/CR‐A), and 3.) Bendamustine, Rituximab and Acalabrutinib (BR‐A) in Patients <= 70 Years Old with Untreated Mantle Cell Lymphoma

S1608 II Randomized Phase II Trial in Early Relapsing or Refractory Follicular Lymphoma

S1826 III

A Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

EAY131 II Molecular Analysis for Therapy Choice (MATCH)

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 22: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Cross-disease trials:

Mye

lom

aAsymptomatic high-risk smoldering

diease without prior treatment EAA173

Initial induction therapy for transplant eligible multiple myeloma or within 180

days of autotransplant completionS1803 (DRAMMATIC)

Relapsed disease, and subsequently progressed on Lenalidomide

(Lenalidomide-refractory disease)A061202

Symptomatic relapsed/refractory (t(11;14) status must be determined) EAA172

EAY131 (MATCH) S1609 (DART)

NCTN Myeloma Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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NCTN Myeloma Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A061202 I/IIA Phase I/II Study of Pomalidomide, Dexamethasone and Ixazomib VS. Pomalidomide and Dexamethasone for Patients with Multiple Myeloma Refractory to Lenalidomide‐Based Therapy

EAA172 IIPhase 1/2 Study of Daratumumab, Bortezomib, Dexamethasone with or Without Venetoclax in Relapsed/Refractory Multiple Myeloma with Assessment for t(11;14) Status

EAA173 III Daratumumab to Enhance Therapeutic Effectiveness of Revlimid in Smoldering Myeloma (DETER‐SMM)

S1803 III

Phase III Study of Daratumumab/rHuPH20 (NSC‐ 810307) + Lenalidomide or Lenalidomide as Post‐Autologous Stem Cell Transplant Maintenance Therapy in Patients with Multiple Myeloma (MM) Using Minimal Residual Disease to Direct Therapy Duration (DRAMMATIC Study)

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 24: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

NCTN Sarcoma Trials Portfolio (Open as of 5/15/2020) Click on trial number to go to the associated ClinicalTrials.gov webpage, to view the protocol title and study information.

Recurrent DiseaseNewly Diagnosed Disease

Legend by Disease Types

Green = Soft Tissue Sarcoma Orange = Bone Sarcoma 

Soft Tissue Sarcoma

ARST1431Bone Sarcoma

ADVL1622

^: Only NRG participating

NRG‐DT001^

EAY131 (MATCH)

Cross‐disease trial:

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NCTN Sarcoma Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

ADVL1622 IIPhase 2 Trial of XL184 (Cabozantinib) an Oral Small‐Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

ARST1431 IIIA Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

NRG‐DT001^ I A Phase Ib Trial of Neoadjuvant AMG‐232 Concurrent with Preoperative Radiotherapy in Wild‐Type P53 Soft Tissue Sarcoma (STS)EAY131 II Molecular Analysis for Therapy Choice (MATCH)

^: Only NRG participating.

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

Page 26: NCTN Trial Portfolios - National Cancer Institute · NCTN Trial Portfolios Note: For full functionality, it is recommended that users download the , and open with a PDF reader. Cancer

Cross-disease trials:

Skin

Melanoma

Various origins/sub-

types

Unresectable stage III or IV

BRAF V600 mutated EA6134

BRAF wild-type or

mutatedEA6141

Prior anti-PD-1 or anti-PD-

L1 agents

S1607

S1616

Resectable stage III or IV S1801

Resectable stage III B/C/D

BRAF V600 mutated EA6183

Desmoplastic Melanoma

Resectable and unresectable; no prior

systemic therapyS1512

Merkel cell tumor

Completely resected, No

metastatic diseaseEA6174

Squamous cell

carcinoma of the skin

Metastatic or locally advanced A091802

EAY131 (MATCH) S1609 (DART)

NCTN Skin Cancer Trials Portfolio (Open as of 5/15/2020)Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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NCTN Skin Cancer  Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A091802 IIPhase II Randomized Trial of Avelumab Plus Cetuximab Versus Avelumab Alone in Advanced Cutaneous Squamous Cell Carcinoma of the Skin (cSCC)

EA6134 III

A Randomized Phase III Trial of Dabrafenib + Trametinib Followed by Ipilimumab + Nivolumab at Progression vs. Ipilimumab + Nivolumab Followed by Dabrafenib + Trametinib at Progression in Patients with Advanced BRAFV600 Mutant Melanoma

EA6141 II/IIIRandomized Phase II/III Study of Nivolumab Plus Ipilimumab Plus Sargramostim Versus Nivolumab Plus Ipilimumab in Patients with Unresectable Stage III or Stage IV Melanoma

EA6174 IIIA Phase III Randomized Trial Comparing Adjuvant MK‐3475 (Pembrolizumab) to Standard of Care Observation in Completely Resected Merkel Cell Carcinoma

EA6183 IIA Phase II Neoadjuvant Study of Encorafenib with Binimetinib in Patients with Resectable Locoregional Metastases From Cutaneous or Unknown Primary Melanoma (Stages III N1B/C/D)

S1512 II A Phase II and Pilot Trial of PD‐1 Blockade with MK‐3475 (Pembrolizumab) in Patients with Resectable or Unresectable Desmoplastic Melanoma (DM)

S1607 II

A Phase II Study of Combining Talimogene Laherparepvec T‐VEC (NSC‐785349) and MK‐3475 (Pembrolizumab) (NSC‐776864) in Patients with Advanced Melanoma Who Have Progressed on Anti‐PD1/L1 Based Therapy

S1616 IIA Phase II Randomized Study of Nivolumab (NSC‐748726) with Ipilimumab (NSC‐732442) or Ipilimumab Alone in Advanced Melanoma Patients Refractory to an Anti‐PD1 or Anti‐PD‐L1 Agent

S1801 IIA Phase II Randomized Study of Adjuvant Versus NeoAdjuvant MK‐3475 (Pembrolizumab) for Clinically Detectable Stage III‐IV High‐Risk Melanoma

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

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Thor

acic

Non-small cell

lung cancer

Newly diagnosed, T1-3N0M0, high risk S1914

Completely resected stage IB (≥ 4 cm), II or

IIIA with negative margins

A151216 (ALCHEMIST-

SCREEN)

Non-squamous, EGFR mutation A081105

Non-squamous, ALK fusion positive E4512

Stage II-III, with non-operable, non-

metastatic disease

RTOG-1308PD-L1 high expression NRG-LU004

Newly diagnosed, unresectable, stage IIIA/B/C EA5181Stage IV, stage IIIB not amenable to definitive multi-

modality therapy, or recurrent; EGFR exon 20 insertion mutation

EA5162

Stage IV, non-squamous disease, PD-L1 positive (TPS ≥ 1%) EA5163

Stage IV disease NRG-LU002

Stage IV, non-Squamous; ALK-positive; Previously treated progressive disease NRG-LU003

Previously-treated, stage IV

or recurrent

LUNGMAP Screening

Study

Anti-PD-1/PD-L1 inhibitor resistant S1800A

LOH high and/or BRCA1/2 deleterious

mutationS1900A

RET fusion-positive S1900B

STK11 genomic alterations S1900C

Small cell lung cancer

Limited stage NRG-LU005

All stages, no brain Mets S1827

Mesothelioma Stage I-IIIA, resectable NRG-LU006

Lung carcinoid tumor Progressed disease A021602 (CABINET)

Thymic Carcinoma

Unresectable, locally advanced, recurrent, or metastatic S1701

NCTN Thoracic Cancer Trials Portfolio (Open as of 5/15/2020) Each far right box includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

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EAY131 (MATCH) S1609 (DART)

NCTN Thoracic Cancer Trials Portfolio (Open as of 5/15/2020)Each box below includes the NCTN protocol number with a hyperlink to the associated ClinicalTrials.gov webpage. Click on it to view the protocol title and study information.

Cross-disease trials:

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NCTN Thoracic Cancer Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A021602 IIIRandomized, Double‐Blinded Phase III Study of CABozantinib Versus Placebo IN Patients with Advanced NEuroendocrine Tumors After Progression on Everolimus (CABINET)

A081105 IIIRandomized Study of Erlotinib Vs Observation in Patients With Completely Resected Epidermal Growth Factor Receptor (EGFR) Mutant Non‐Small Cell Lung Cancer (NSCLC)

A151216 Other Adjuvant Lung Cancer Enrichment Marker Identification and Sequencing Trial (ALCHEMIST)

E4512 III

A Randomized Phase III Trial for Surgically Resected Early Stage Non‐Small Cell Lung Cancer: Crizotinib Versus Observation for Patients with Tumors Harboring the Anaplastic Lymphoma Kinase (ALK) Fusion Protein

EA5162 IIPhase II Study of AZD9291 (Osimertinib) in Advanced NSCLC Patients with Exon 20 Insertion Mutations in EGFR

EA5163 III

EA5163/S1709 INSIGNA : A Randomized, Phase III Study of Firstline Immunotherapy Alone or in Combination with Chemotherapy in Induction/Maintenance or Postprogression in Advanced Nonsquamous Non‐Small Cell Lung Cancer (NSCLC) with Immunobiomarker SIGNature‐Driven Analysis

EA5181 IIIRandomized Phase III Trial of MEDI4736 (Durvalumab) as Concurrent and Consolidative Therapy or Consolidative Therapy Alone for Unresectable Stage 3 NSCLC

LUNGMAP IIA Master Protocol to Evaluate Biomarker‐Driven Therapies and Immunotherapies in Previously‐Treated Non‐Small Cell Lung Cancer (Lung‐MAP Screening Study)

NRG‐LU002 II/III

Maintenance Systemic Therapy Versus Consolidative Stereotactic Body Radiation Therapy (SBRT) Plus Maintenance Systemic Therapy for Limited Metastatic Non‐Small Cell Lung Cancer (NSCLC): A Randomized Phase II/III Trial

NRG‐LU003 IIA Biomarker‐Driven Protocol for Previously Treated ALK‐Positive Non‐Squamous NSCLC Patients: The NCI‐NRG ALK Master Protocol

NRG‐LU004 I

Phase I Trial of Accelerated or Conventionally Fractionated Radiotherapy Combined with MEDI4736 (Durvalumab) in PD‐L1 High Locally Advanced Non‐Small Cell Lung Cancer (NSCLC) (ARCHON‐1)

NRG‐LU005 II/IIILimited Stage Small Cell Lung Cancer (LS‐SCLC): A Phase II/III Randomized Study of Chemoradiation Versus Chemoradiation Plus Atezolizumab

NRG‐LU006 III

Phase III Randomized Trial of Pleurectomy/Decortication Plus Chemotherapy with or Without Adjuvant Hemithoracic Intensity‐Modulated Pleural Radiation Therapy (IMPRINT) For Malignant Pleural Mesothelioma (MPM)

RTOG‐1308 IIIPhase III Randomized Trial Comparing Overall Survival After Photon Versus Proton Chemoradiotherapy for Inoperable Stage II‐IIIB NSCLC

S1701 IIA Randomized Phase II Trial of Carboplatin‐Paclitaxel with or Without Ramucirumab in Patients with Unresectable Locally Advanced, Recurrent, or Metastatic Thymic Carcinoma

S1800A II

A Phase II Randomized Study of Ramucirumab Plus MK3475 (Pembrolizumab) Versus Standard of Care for Patients Previously Treated with Immunotherapy for Stage IV or Recurrent Non‐Small Cell Lung Cancer (Lung‐MAP Non‐Matched Sub‐Study)

S1827 IIIA Randomized Phase III Trial of MRI Surveillance with or Without Prophylactic Cranial Irradiation (PCI) in Small‐Cell Lung Cancer

S1900A IIA Phase II Study of Rucaparib in Patients with Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non‐Small Cell Lung Cancer (LUNG‐MAP Sub‐Study)

S1900B IIA Phase II Study of LOXO‐292 in Patients with RET Fusion‐Positive Stage IV or Recurrent Non‐Small Cell Lung Cancer (LUNG‐MAP Sub‐Study)

S1900C II

A Phase II Study of Talazoparib Plus Avelumab in Patients with Stage IV or Recurrent Non‐Squamous Non‐Small Cell Lung Cancer Bearing Pathogenic STK11 Genomic Alterations (LUNG‐MAP Sub‐Study)

S1914 IIIA Randomized Phase III Trial of Induction/Consolidation Atezolizumab (NSC #783608) + SBRT Versus SBRT Alone in High Risk, Early Stage NSCLC

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609 II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/

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NCTN Adolescent to Young Adult (AYA) Cancer Trials Portfolio (Open as of 5/15/2020) Click on trial number to go to the associated ClinicalTrials.gov webpage, to view the protocol title and the study information.

Recurrent DiseaseNewly Diagnosed Disease

Legend by Disease Types

Green = Soft Tissue Sarcoma Orange = Bone Tumors  Yellow = Germ Cell Tumors

Soft Tissue Sarcoma

ARST1431

Germ Cell Tumors

AGCT1531

Bone Tumors

ADVL1622

Germ Cell Tumors

A031102 (TIGER)

Cross‐disease trials

EAY131 (MATCH) S1609 (DART)*

AGCT1532

Acute Lymphoblastic Leukemia (ALL)

A041501*

Blue = ALL

TFE/Translocation Renal Cell Carcinoma (tRCC) 

AREN1721

Purple = tRCC

Classical Hodgkin Lymphoma

S1826

*: COG not participating

Lime green = Hodgkin Lymphoma

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NCTN Adolescent to Young Adult (AYA) Cancer Trials (Open as of 5/15/2020)

Protocol Number Phase Protocol Title

A031102 III

A Randomized Phase III Trial Comparing Conventional‐Dose Chemotherapy Using Paclitaxel, Ifosfamide, and Cisplatin (TIP) with High‐Dose Chemotherapy Using Mobilizing Paclitaxel Plus Ifosfamide Followed by High‐Dose Carboplatin and Etoposide (TI‐CE) as First Salvage Treatment in Relapsed or Refractory Germ Cell Tumors

A041501* IIIA Phase III Trial to Evaluate the Efficacy of the Addition of Inotuzumab Ozogamicin (a Conjugated Anti‐CD22 Monoclonal Antibody) to Frontline Therapy in Young Adults (Ages 18‐39 Years) with Newly Diagnosed Precursor B‐Cell ALL

ADVL1622 IIPhase 2 Trial of XL184 (Cabozantinib) an Oral Small‐Molecule Inhibitor of Multiple Kinases, in Children and Young Adults with Refractory Sarcomas, Wilms Tumor, and Other Rare Tumors

AGCT1531 IIIA Phase 3 Study of Active Surveillance for Low Risk and a Randomized Trial of Carboplatin vs. Cisplatin for Standard Risk Pediatric and Adult Patients with Germ Cell Tumors

AGCT1532 IIIA Randomized Phase 3 Trial of Accelerated Versus Standard BEP Chemotherapy for Patients with Intermediate and Poor‐Risk Germ Cell Tumors

AREN1721 IIA Randomized Phase 2 Trial of Axitinib/Nivolumab Combination Therapy vs. Single Agent Axitinib or Nivolumab for the Treatment of TFE/Translocation Renal Cell Carcinoma (tRCC) Across All Age Groups

ARST1431 IIIA Randomized Phase 3 Study of Vincristine, Dactinomycin, Cyclophosphamide (VAC) Alternating with Vincristine and Irinotecan (VI) Versus VAC/VI Plus Temsirolimus (TORI, Torisel, NSC# 683864) in Patients with Intermediate Risk (IR) Rhabdomyosarcoma (RMS)

S1826 IIIA Phase III, Randomized Study of Nivolumab (Opdivo) Plus AVD or Brentuximab Vedotin (Adcetris) Plus AVD in Patients (Age >/= 12 Years) with Newly Diagnosed Advanced Stage Classical Hodgkin Lymphoma

EAY131 II Molecular Analysis for Therapy Choice (MATCH)S1609* II DART: Dual Anti‐CTLA‐4 and Anti‐PD‐1 Blockade in Rare Tumors

*: COG not participating

This portfolio shows NCTN trials. For information about NCORP trials, please see: https://ncorp.cancer.gov/find‐a‐study/