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A Phase 1/2 Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV Non-small Cell Lung Cancer That Has Spread or Has Reoccurred After Failure of Chemotherapy and Immunotherapy

NCT04151563

Description:

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

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

Not yet recruiting

Phase:

Phase 1/Phase 2

Trial Eligibility

Document

Title

  • Brief Title: A Phase 1/2 Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV Non-small Cell Lung Cancer That Has Spread or Has Reoccurred After Failure of Chemotherapy and Immunotherapy
  • Official Title: A Phase 1/2, Randomized Study Evaluating Multiple Nivolumab Combination Therapy in Participants With Stage IV or Recurrent Non-Small Cell Lung Cancer (NSCLC) After Failure of Platinum-Based Chemotherapy and Anti-PD-1 (L1) Immunotherapy

Clinical Trial IDs

  • ORG STUDY ID: CA209-79X
  • NCT ID: NCT04151563

Conditions

  • Carcinoma, Non-small Cell Lung

Interventions

DrugSynonymsArms
nivolumabArm A: cabozantinib + nivolumab + ipilimumab
ipilimumabArm A: cabozantinib + nivolumab + ipilimumab
cabozantinibArm A: cabozantinib + nivolumab + ipilimumab
docetaxelArm C: nivolumab + ramucirumab + docetaxel
ramucirumabArm C: nivolumab + ramucirumab + docetaxel
lucitanibArm 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 or 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:

          -  Stage IV non-small cell lung Cancer, stage IIIB/C disease failed concurrent chemoRT

          -  ECOG Performance Status of ≤ 1

          -  Clinically documented or radiographically documented disease progression/recurrence
             during or after the last dose of treatment

          -  Progression on one anti-PD-1/anti-PD-L1 therapy and one platinum-based doublet regimen
             given either concurrently or sequentially

          -  Radiographic disease progression or recurrence during or within 90 days after the last
             dose of durvalumab for locally advanced disease

          -  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.

          -  Toxicities must be 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

          -  Active brain 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

          -  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)
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)
Time Frame:approximately 33 months
Safety Issue:
Description:
Measure:Progression-Free Survival (PFS)
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:

Details

Phase:Phase 1/Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:Bristol-Myers Squibb

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