Clinical Trials /

A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy

NCT04151563

Description:

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

Related Conditions:
  • Non-Small Cell Lung Carcinoma
Recruiting Status:

Withdrawn

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Clinical Study Evaluating Nivolumab-containing Treatments in Patients With Advanced Non-small Cell Lung Cancer After Failing Previous PD-1/(L)1 Therapy and Chemotherapy
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: CA209-79X
  • SECONDARY ID: 2018-004283-65
  • NCT ID: NCT04151563

Conditions

  • Carcinoma, Non-small Cell Lung Cancer

Interventions

DrugSynonymsArms
nivolumabOPDIVO, BMS-936558Arm A: cabozantinib + nivolumab + ipilimumab
ipilimumabYERVOYArm A: cabozantinib + nivolumab + ipilimumab
cabozantinibCABOMETYXArm A: cabozantinib + nivolumab + ipilimumab
docetaxelArm C: nivolumab + ramucirumab + docetaxel
ramucirumabCYRAMZAArm C: nivolumab + ramucirumab + docetaxel
lucitanibCO-3810Arm D: lucitanib + nivolumab

Purpose

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

Trial Arms

NameTypeDescriptionInterventions
Arm A: cabozantinib + nivolumab + ipilimumabExperimental
  • nivolumab
  • ipilimumab
  • cabozantinib
Arm B: cabozantinib + nivolumabExperimental
  • nivolumab
  • cabozantinib
Arm C: nivolumab + ramucirumab + docetaxelExperimental
  • nivolumab
  • docetaxel
  • ramucirumab
Arm D: lucitanib + nivolumabExperimental
  • nivolumab
  • lucitanib
Arm E: nivolumab + docetaxelExperimental
  • nivolumab
  • docetaxel
Arm F: docetaxelActive Comparator
  • docetaxel

Eligibility Criteria

        For more information regarding Bristol-Myers Squibb Clinical Trial participation, please
        visit www.BMSStudyConnect.com

        Inclusion Criteria:

          -  Histologically or cytologically-documented Stage IV A/B non-small cell lung Cancer,
             stage IIIB/C disease failed concurrent chemoRT

          -  ECOG Performance Status of ≤ 1

          -  Radiologically-documented disease progression on one anti-PD-1/anti-PD-L1 therapy and
             one platinum-based doublet regimen given either concurrently or sequentially within 90
             days after the last dose of anti-PD-(L)1

          -  All participants must have tumor tissue submitted prior to randomization, either a
             recent archival sample obtained on/after the date of disease progression of the last
             prior anticancer therapy and within 3 months prior to enrollment, or a fresh biopsy
             obtained during the screening period.

          -  Prior toxicities must have resolved to grade ≤1

          -  Women of childbearing potential (WOCBP) must have a negative serum or urine pregnancy
             test and must not be breastfeeding

          -  Males who are sexually active with WOCBP must agree to follow instructions for
             method(s) of contraception. In addition, male participants must be willing to refrain
             from sperm donation during this time and must agree to follow instructions for
             method(s) of contraception. Azoospermic males are exempt from contraceptive
             requirements as well as WOCBP who are continuously not heterosexually active, however,
             a pregnancy test will still be required.

        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
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:All
Healthy Volunteers:No

Primary Outcome Measures

Measure:Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
Time Frame:approximately 33 months
Safety Issue:
Description:

Secondary Outcome Measures

Measure:Overall Survival (OS)
Time Frame:Up to 5 Years
Safety Issue:
Description:
Measure:Duration of Response (DOR) by BICR using RECIST 1.1
Time Frame:approximately 33 months
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS) by BICR using RECIST 1.1
Time Frame:Up to 5 Years
Safety Issue:
Description:
Measure:Incidence of Adverse Events (AEs)
Time Frame:Up to 5 Years
Safety Issue:
Description:
Measure:Incidence of Serious Adverse Events (SAEs)
Time Frame:Up to 5 Years
Safety Issue:
Description:
Measure:Incidence of Select AEs
Time Frame:Up to 5 Years
Safety Issue:
Description:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Withdrawn
Lead Sponsor:Bristol-Myers Squibb

Last Updated

February 17, 2021