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Report for Clinical Trial NCT04151563

Developed by Shray Alag, 2020.
SNP Clinical Trial Gene

A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapies in Patients With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L)1 Immunotherapy

This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy

NCT04151563 Carcinoma, Non-small Cell Lung Cancer
MeSH:Lung Neoplasms Carcinoma, Non-Small-Cell Lung
HPO:Neoplasm of the lung Non-small cell lung carcinoma

6 Interventions

Name: nivolumab

Description: Specified dose on Specified days
Type: Biological
Group Labels: 5

Arm A: cabozantinib + nivolumab + ipilimumab Arm B: cabozantinib + nivolumab Arm C: nivolumab + ramucirumab + docetaxel Arm D: lucitanib + nivolumab Arm E: nivolumab + docetaxel

Name: ipilimumab

Description: Specified dose on Specified days
Type: Biological
Group Labels: 1

Arm A: cabozantinib + nivolumab + ipilimumab

Name: cabozantinib

Description: Specified dose on Specified days
Type: Drug
Group Labels: 2

Arm A: cabozantinib + nivolumab + ipilimumab Arm B: cabozantinib + nivolumab

Name: docetaxel

Description: Specified dose on Specified days
Type: Biological
Group Labels: 3

Arm C: nivolumab + ramucirumab + docetaxel Arm E: nivolumab + docetaxel Arm F: docetaxel

Name: ramucirumab

Description: Specified dose on Specified days
Type: Biological
Group Labels: 1

Arm C: nivolumab + ramucirumab + docetaxel

Name: lucitanib

Description: Specified dose on Specified days
Type: Drug
Group Labels: 1

Arm D: lucitanib + nivolumab


Primary Outcomes

Measure: Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment

Time: approximately 33 months

Secondary Outcomes

Measure: Overall Survival (OS)

Time: Up to 5 Years

Measure: Duration of Response (DOR) by BICR using RECIST 1.1

Time: approximately 33 months

Measure: Progression-Free Survival (PFS) by BICR using RECIST 1.1

Time: Up to 5 Years

Measure: Incidence of Adverse Events (AEs)

Time: Up to 5 Years

Measure: Incidence of Serious Adverse Events (SAEs)

Time: Up to 5 Years

Measure: Incidence of Select AEs

Time: Up to 5 Years

Purpose: Treatment

Allocation: Randomized

Parallel Assignment


There is one SNP

SNPs


1 V600E

Exclusion Criteria - Prior treatment with Docetaxel - Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases - Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea - EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy - History of cerebrovascular accident and coagulation disorders - Participants with interstital lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization - Known toxicity on prior checkpoint inhibitor treatment - Participants who received more than one line of anti- PD-1/PD-L1 treatment - Participants who received previous CTLA-4 inhibitor treatment - Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded Other protocol defined inclusion/exclusion criteria could apply For more information regarding Bristol-Myers Squibb Clinical Trial participation, please visit www.BMSStudyConnect.com --- V600E ---

Exclusion Criteria - Prior treatment with Docetaxel - Untreated CNS metastases, carcinomatous meningitis or leptomeningeal metastases - Any tumor invading the Superior Vena Cava other blood vessel, GI Tract or Trachea - EGFR mutations, ALK translocations, ROS1 translocations which are sensitive to inhibitor therapy - History of cerebrovascular accident and coagulation disorders - Participants with interstital lung disease, history of cerebrovascular accident or history of abdominal fistula, gastrointestinal perforation, bowel obstruction, intra-abdominal abscess or grade 3-4 bleeding event within 6 months prior to randomization - Known toxicity on prior checkpoint inhibitor treatment - Participants who received more than one line of anti- PD-1/PD-L1 treatment - Participants who received previous CTLA-4 inhibitor treatment - Participants with known BRAF V600E mutation which are sensitive to available targeted inhibitor therapy are excluded Other protocol defined inclusion/exclusion criteria could apply Carcinoma, Non-small Cell Lung Cancer Lung Neoplasms Carcinoma, Non-Small-Cell Lung null --- V600E ---



HPO Nodes


HPO: