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
NCT ID: NCT04151563
Last Updated: 2023-12-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE1/PHASE2
INTERVENTIONAL
2021-04-15
2026-05-13
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Arm A: cabozantinib + nivolumab + ipilimumab
nivolumab
Specified dose on Specified days
ipilimumab
Specified dose on Specified days
cabozantinib
Specified dose on Specified days
Arm B: cabozantinib + nivolumab
nivolumab
Specified dose on Specified days
cabozantinib
Specified dose on Specified days
Arm C: nivolumab + ramucirumab + docetaxel
nivolumab
Specified dose on Specified days
docetaxel
Specified dose on Specified days
ramucirumab
Specified dose on Specified days
Arm D: lucitanib + nivolumab
nivolumab
Specified dose on Specified days
lucitanib
Specified dose on Specified days
Arm E: nivolumab + docetaxel
nivolumab
Specified dose on Specified days
docetaxel
Specified dose on Specified days
Arm F: docetaxel
docetaxel
Specified dose on Specified days
Interventions
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nivolumab
Specified dose on Specified days
ipilimumab
Specified dose on Specified days
cabozantinib
Specified dose on Specified days
docetaxel
Specified dose on Specified days
ramucirumab
Specified dose on Specified days
lucitanib
Specified dose on Specified days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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 interstitial 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.
18 Years
ALL
No
Sponsors
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Clovis Oncology, Inc.
INDUSTRY
Exelixis
INDUSTRY
Eli Lilly and Company
INDUSTRY
Bristol-Myers Squibb
INDUSTRY
Responsible Party
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Principal Investigators
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Bristol-Myers Squibb
Role: STUDY_DIRECTOR
Bristol-Myers Squibb
Locations
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Local Institution
Detroit, Michigan, United States
Local Institution
Ciudad Autónoma de Buenos Aires, Buenos Aires, Argentina
Local Institution
Buenos Aires, Distrito Federal, Argentina
Local Institution
Buenos Aires, Distrito Federal, Argentina
Local Institution
Caba, Distrito Federal, Argentina
Local Institution
Capital, Distrito Federal, Argentina
Local Institution
Charleroi, , Belgium
Local Institution
Gilly, , Belgium
Local Institution
Leuven, , Belgium
Local Institution
Copenhagen Ø, , Denmark
Local Institution
Athens, , Greece
Local Institution
Neo Faliro, , Greece
Local Institution
Torreón, Coahuila, Mexico
Local Institution
Zapopan, Jalisco, Mexico
Local Institution
Mexico City, Mexico City, Mexico
Local Institution
Puebla City, Puebla, Mexico
Local Institution
Amsterdam, , Netherlands
Local Institution
Rotterdam, , Netherlands
Local Institution
Oslo, , Norway
Local Institution
Warsaw, Masovian Voivodeship, Poland
Local Institution
Krakow, , Poland
Local Institution
Craiova, , Romania
Local Institution
Timișoara, , Romania
Countries
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Related Links
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BMS Clinical Trial Information
BMS Clinical Trial Patient Recruiting
FDA Safety Alerts and Recalls
Other Identifiers
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2018-004283-65
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CA209-79X
Identifier Type: -
Identifier Source: org_study_id