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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 (CheckMate 79X)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04151563
Recruitment Status : Withdrawn (Business objectives have changed)
First Posted : November 5, 2019
Last Update Posted : February 17, 2021
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 and Immunotherapy

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

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 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 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
Estimated Study Start Date : April 15, 2021
Estimated Primary Completion Date : December 17, 2023
Estimated Study Completion Date : May 13, 2026

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
Other Names:
  • OPDIVO
  • BMS-936558

Biological: ipilimumab
Specified dose on Specified days
Other Name: YERVOY

Drug: cabozantinib
Specified dose on Specified days
Other Name: CABOMETYX

Experimental: Arm B: cabozantinib + nivolumab Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Drug: cabozantinib
Specified dose on Specified days
Other Name: CABOMETYX

Experimental: Arm C: nivolumab + ramucirumab + docetaxel Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Biological: docetaxel
Specified dose on Specified days

Biological: ramucirumab
Specified dose on Specified days
Other Name: CYRAMZA

Experimental: Arm D: lucitanib + nivolumab Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Drug: lucitanib
Specified dose on Specified days
Other Name: CO-3810

Experimental: Arm E: nivolumab + docetaxel Biological: nivolumab
Specified dose on Specified days
Other Names:
  • OPDIVO
  • BMS-936558

Biological: docetaxel
Specified dose on Specified days

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




Primary Outcome Measures :
  1. Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment [ Time Frame: approximately 33 months ]

Secondary Outcome Measures :
  1. Overall Survival (OS) [ Time Frame: Up to 5 Years ]
  2. Duration of Response (DOR) by BICR using RECIST 1.1 [ Time Frame: approximately 33 months ]
  3. Progression-Free Survival (PFS) by BICR using RECIST 1.1 [ 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 ]
  6. Incidence of Select AEs [ Time Frame: Up to 5 Years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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:

  • 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


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, Michigan
Local Institution
Detroit, Michigan, United States, 48201
Argentina
Local Institution
Caba, Buenos Aires, Argentina, 1430
Local Institution
Ciudad Autónoma De Buenos Aires, Buenos Aires, Argentina, 1426
Local Institution
Buenos Aires, Distrito Federal, Argentina, 1431
Local Institution
Buenos Aires, Distrito Federal, Argentina, C1199ABB
Local Institution
Capital, Distrito Federal, Argentina, C1280
Belgium
Local Institution
Charleroi, Belgium, 6000
Local Institution
Gilly, Belgium, 6060
Local Institution
Leuven, Belgium, 3000
Chile
Local Institution
Santiago, Metropolitana, Chile, 7500921
Local Institution
Santiago, Metropolitana, Chile, 8420383
Denmark
Local Institution
Copenhagen ?, Denmark, 2100
France
Local Institution
Nantes, France, 44093
Local Institution
Paris Cedex 5, France, 75248
Local Institution
Rennes, France, 35033
Greece
Local Institution
Athens, Greece, 11527
Local Institution
Neo Faliro, Greece, 18547
Mexico
Local Institution
Torreon, Coahuila, Mexico, 27010
Local Institution
Ciudad de Mexico, Distrito Federal, Mexico, 03240
Local Institution
Zapopan, Jalisco, Mexico, 44280
Local Institution
Heroica Puebla de Zaragoza, Puebla, Mexico, 72530
Netherlands
Local Institution
Amsterdam, Netherlands, 1066 CX
Local Institution
Rotterdam, Netherlands, 3015 GD
Norway
Local Institution
Oslo, Norway, 0379
Poland
Local Institution
Warszawa, Mazowieckie, Poland, 02-781
Local Institution
Krakow, Poland, 30-688
Romania
Local Institution
Craiova, Romania, 200347
Local Institution
Timisoara, Romania, 300696
Spain
Local Institution
A Coru?a, Spain, 15006
Local Institution
Barcelona, Spain, 08035
Local Institution
Barcelona, Spain, 08036
Local Institution
Madrid, Spain, 28041
Local Institution
Majadahonda - Madrid, Spain, 28222
Local Institution
Malaga, Spain, 29010
Local Institution
Santiago Compostela, Spain, 15706
Local Institution
Sevilla, Spain, 41014
Local Institution
Valencia, Spain, 46026
Sponsors and Collaborators
Bristol-Myers Squibb
Clovis Oncology, Inc.
Exelixis
Eli Lilly and Company
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT04151563    
Other Study ID Numbers: CA209-79X
2018-004283-65 ( EudraCT Number )
First Posted: November 5, 2019    Key Record Dates
Last Update Posted: February 17, 2021
Last Verified: February 2021

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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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Lung Neoplasms
Carcinoma, Non-Small-Cell Lung
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases
Carcinoma, Bronchogenic
Bronchial Neoplasms
Docetaxel
Nivolumab
Ipilimumab
Ramucirumab
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents, Immunological