Carcinoma, Non-small Cell Lung CancerPhase 1/2CheckMate 79XNCT04151563
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
A Phase 1/2 study testing nivolumab, ipilimumab and cabozantinib in people with Carcinoma, Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 23 sites in 10 countries.
Trial summary
This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Carcinoma, Non-small Cell Lung Cancer
- What is being tested?
- nivolumab, ipilimumab and cabozantinib
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 23 sitesin 10 countries
- Study dates
- 15 Apr 2021to 13 May 2026
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 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.
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- 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 apply.
Trial locations and contacts
23 sites in 10 countries.
23 sites in 10 countries
Argentina5 sites
Local Institution
Buenos Aires, Distrito Federal, 1431
Local Institution
Buenos Aires, Distrito Federal, C1199ABB
Local Institution
Caba, Distrito Federal, 1430
Local Institution
Capital, Distrito Federal, C1280
Local Institution
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1426
Mexico4 sites
Local Institution
Mexico City, Mexico City, 03240
Local Institution
Puebla City, Puebla, 72530
Local Institution
Torreón, Coahuila, 27010
Local Institution
Zapopan, Jalisco, 44280
Belgium3 sites
Local Institution
Charleroi, 6000
Local Institution
Gilly, 6060
Local Institution
Leuven, 3000
Greece2 sites
Local Institution
Athens, 11527
Local Institution
Neo Faliro, 18547
Netherlands2 sites
Local Institution
Amsterdam, 1066 CX
Local Institution
Rotterdam, 3015 GD
Poland2 sites
Local Institution
Krakow, 30-688
Local Institution
Warsaw, Masovian Voivodeship, 02-781
Romania2 sites
Local Institution
Craiova, 200347
Local Institution
Timișoara, 300696
About this study
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
This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy
- Conditions
- Carcinoma, Non-small Cell Lung Cancer
- Being tested
- nivolumab, ipilimumab, cabozantinib, docetaxel, ramucirumab
- Medical subject headings
- Carcinoma, Carcinoma, Non-Small-Cell Lung
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
nivolumabBiological
Also called OPDIVO, BMS-936558
Specified dose on Specified days
ipilimumabBiological
Also called YERVOY
Specified dose on Specified days
cabozantinibDrug
Also called CABOMETYX
Specified dose on Specified days
docetaxelBiological
Specified dose on Specified days
ramucirumabBiological
Also called CYRAMZA
Specified dose on Specified days
lucitanibDrug
Also called CO-3810
Specified dose on Specified days
| Study group | Role | What they receive |
|---|---|---|
| Arm A: cabozantinib + nivolumab + ipilimumab | Experimental | Not described Receives: Biological: nivolumab; Biological: ipilimumab; Drug: cabozantinib |
| Arm B: cabozantinib + nivolumab | Experimental | Not described Receives: Biological: nivolumab; Drug: cabozantinib |
| Arm C: nivolumab + ramucirumab + docetaxel | Experimental | Not described Receives: Biological: nivolumab; Biological: docetaxel; Biological: ramucirumab |
| Arm D: lucitanib + nivolumab | Experimental | Not described Receives: Biological: nivolumab; Drug: lucitanib |
| Arm E: nivolumab + docetaxel | Experimental | Not described Receives: Biological: nivolumab; Biological: docetaxel |
| Arm F: docetaxel | Active comparator | Not described Receives: Biological: docetaxel |
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
Measured: approximately 33 months
Secondary outcomes (6)
Overall Survival (OS)
Measured: Up to 5 Years
Duration of Response (DOR) by BICR using RECIST 1.1
Measured: approximately 33 months
Progression-Free Survival (PFS) by BICR using RECIST 1.1
Measured: Up to 5 Years
Incidence of Adverse Events (AEs)
Measured: Up to 5 Years
Incidence of Serious Adverse Events (SAEs)
Measured: Up to 5 Years
Incidence of Select AEs
Measured: Up to 5 Years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start15 Apr 2021 (estimated)
- Primary completion17 Dec 2023 (estimated)
- Study completion13 May 2026 (estimated)
Why it stopped: Business objectives have changed
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carcinoma, Non-small Cell Lung CancerStudies of the same condition, open and under way.
- More trials run by Bristol-Myers SquibbThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Clovis Oncology, Inc., Exelixis, Eli Lilly and Company
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04151563
- Sponsor's protocol ID
- CA209-79X
- Other IDs
- 2018-004283-65, 2018
- Acronym
- CheckMate 79X
- Status last verified
- Dec 2023
- First submitted
- 1 Nov 2019
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04151563
- Acronym / sponsor ID
- CheckMate 79X / CA209-79X
- Conditions
- Carcinoma, Non-small Cell Lung Cancer
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Business objectives have changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Collaborators
- Clovis Oncology, Inc., Exelixis, Eli Lilly and Company
- Study start
- 15 Apr 2021 (estimated)
- Primary completion
- 17 Dec 2023 (estimated)
- Study completion
- 13 May 2026 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is for participants with Non-small Cell Lung Cancer that has spread or has reoccurred after failure of Chemotherapy and Immunotherapy
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Arm A: cabozantinib + nivolumab + ipilimumab | Experimental | Biological: nivolumab, Biological: ipilimumab, Drug: cabozantinib |
| Arm B: cabozantinib + nivolumab | Experimental | Biological: nivolumab, Drug: cabozantinib |
| Arm C: nivolumab + ramucirumab + docetaxel | Experimental | Biological: nivolumab, Biological: docetaxel, Biological: ramucirumab |
| Arm D: lucitanib + nivolumab | Experimental | Biological: nivolumab, Drug: lucitanib |
| Arm E: nivolumab + docetaxel | Experimental | Biological: nivolumab, Biological: docetaxel |
| Arm F: docetaxel | Active comparator | Biological: docetaxel |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| nivolumabAlso: OPDIVO, BMS-936558Specified dose on Specified days | Biological | Arm A: cabozantinib + nivolumab + ipilimumab, Arm B: cabozantinib + nivolumab, Arm C: nivolumab + ramucirumab + docetaxel, Arm D: lucitanib + nivolumab, Arm E: nivolumab + docetaxel |
| ipilimumabAlso: YERVOYSpecified dose on Specified days | Biological | Arm A: cabozantinib + nivolumab + ipilimumab |
| cabozantinibAlso: CABOMETYXSpecified dose on Specified days | Drug | Arm A: cabozantinib + nivolumab + ipilimumab, Arm B: cabozantinib + nivolumab |
| docetaxelSpecified dose on Specified days | Biological | Arm C: nivolumab + ramucirumab + docetaxel, Arm E: nivolumab + docetaxel, Arm F: docetaxel |
| ramucirumabAlso: CYRAMZASpecified dose on Specified days | Biological | Arm C: nivolumab + ramucirumab + docetaxel |
| lucitanibAlso: CO-3810Specified dose on Specified days | Drug | Arm D: lucitanib + nivolumab |
Primary outcome
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment
Time frame: approximately 33 months
6 secondary outcomes
Overall Survival (OS)
Time frame: Up to 5 Years
Duration of Response (DOR) by BICR using RECIST 1.1
Time frame: approximately 33 months
Progression-Free Survival (PFS) by BICR using RECIST 1.1
Time frame: Up to 5 Years
Incidence of Adverse Events (AEs)
Time frame: Up to 5 Years
Incidence of Serious Adverse Events (SAEs)
Time frame: Up to 5 Years
Incidence of Select AEs
Time frame: Up to 5 Years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2023.
- BMS Clinical Trial InformationLink provided by the sponsor.
- BMS Clinical Trial Patient RecruitingLink provided by the sponsor.
- FDA Safety Alerts and RecallsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bristol-Myers Squibb study director
Bristol-Myers Squibb
23 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing nivolumab, ipilimumab and cabozantinib in people with Carcinoma, Non-small Cell Lung Cancer, run by Bristol-Myers Squibb at 23 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 19 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites in Argentina, Mexico, Belgium, Greece, Netherlands and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall Reponse Rate (ORR) using RECIST 1.1 per Blinded Independent Central Review (BICR) assessment (time frame: approximately 33 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2023.