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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

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ClinicalTrials.gov Identifier: NCT04151563
Recruitment Status : Not yet recruiting
First Posted : November 5, 2019
Last Update Posted : December 6, 2019
Sponsor:
Collaborators:
Clovis Oncology, Inc.
Exelixis
Eli Lilly and Company
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Carcinoma, Non-small Cell Lung Biological: nivolumab Biological: ipilimumab Drug: cabozantinib Drug: docetaxel Biological: ramucirumab Drug: lucitanib Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 660 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Estimated Study Start Date : February 19, 2020
Estimated Primary Completion Date : November 27, 2024
Estimated Study Completion Date : November 27, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Nivolumab

Arm Intervention/treatment
Experimental: Arm A: cabozantinib + nivolumab + ipilimumab Biological: nivolumab
Specified dose on Specified days

Biological: ipilimumab
Specified dose on Specified days

Drug: cabozantinib
Specified dose on Specified days

Experimental: Arm B: cabozantinib + nivolumab Biological: nivolumab
Specified dose on Specified days

Drug: cabozantinib
Specified dose on Specified days

Experimental: Arm C: nivolumab + ramucirumab + docetaxel Biological: nivolumab
Specified dose on Specified days

Drug: docetaxel
Specified dose on Specified days

Biological: ramucirumab
Specified dose on Specified days

Experimental: Arm D: lucitanib + nivolumab Biological: nivolumab
Specified dose on Specified days

Drug: lucitanib
Specified dose on Specified days

Experimental: Arm E: nivolumab + docetaxel Biological: nivolumab
Specified dose on Specified days

Drug: docetaxel
Specified dose on Specified days

Active Comparator: Arm F: docetaxel Drug: docetaxel
Specified dose on Specified days




Primary Outcome Measures :
  1. Overall Reponse Rate (ORR) [ Time Frame: approximately 33 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 Years ]
  2. Duration of Response (DOR) [ Time Frame: approximately 33 months ]
  3. Progression-Free Survival (PFS) [ Time Frame: Up to 5 Years ]
  4. Incidence of Adverse Events (AEs) [ Time Frame: Up to 5 Years ]
  5. Incidence of Serious Adverse Events (SAEs) [ Time Frame: Up to 5 Years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04151563


Locations
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United States, Arkansas
Local Institution Not yet recruiting
Fayetteville, Arkansas, United States, 72703
Contact: Site 0054         
United States, Florida
Local Institution Not yet recruiting
Tampa, Florida, United States, 33612
Contact: Site 0023         
United States, Georgia
Local Institution Not yet recruiting
Marietta, Georgia, United States, 30060
Contact: Site 0001         
United States, Maine
Local Institution Not yet recruiting
Scarborough, Maine, United States, 04074
Contact: Site 0002         
United States, North Carolina
Local Institution Not yet recruiting
Durham, North Carolina, United States, 27710
Contact: Site 0053         
United States, Ohio
Local Institution Not yet recruiting
Cleveland, Ohio, United States, 44109
Contact: Site 0003         
Mexico
Local Institution Not yet recruiting
Torreon, Coahuila, Mexico, 27010
Contact: Site 0009         
Local Institution Not yet recruiting
Guadalajara, Jalisco, Mexico, 44280
Contact: Site 0006         
Poland
Local Institution Not yet recruiting
Warszawa, Mazowieckie, Poland, 02-781
Contact: Site 0011         
Local Institution Not yet recruiting
Krakow, Poland, 31-501
Contact: Site 0012         
Puerto Rico
Local Institution Not yet recruiting
San Juan, Puerto Rico, 00927
Contact: Site 0034         
Local Institution Not yet recruiting
San Juan, Puerto Rico, 917
Contact: Site 0024         
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
Exelixis
Eli Lilly and Company

Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04151563     History of Changes
Other Study ID Numbers: CA209-79X
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: December 6, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Carcinoma, Non-Small-Cell Lung
Carcinoma, Bronchogenic
Bronchial Neoplasms
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Docetaxel
Nivolumab
Ipilimumab
Ramucirumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological