Pan TumorPhase 2CheckMate 848NCT03668119
A Study of Nivolumab Combined With Ipilimumab and Nivolumab Alone in Patients With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
A Phase 2 study testing Nivolumab and Ipilimumab in people with Pan Tumor, run by Bristol-Myers Squibb at 60 sites in 17 countries.
Trial summary
The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Pan Tumor
- What is being tested?
- Nivolumab and Ipilimumab
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 212 participants
- Where
- 60 sitesin 17 countries
- Study dates
- 31 Oct 2018to 2 Aug 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with high tumor mutational burden (TMB-H) who are refractory to standard local therapies, or for which no standard treatment is available.
- Must be able to provide tissue and blood TMB-H testing results
- Must have measurable disease for response assessment
Who cannot join
- Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
- Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment
- Other protocol defined inclusion/exclusion criteria apply.
Trial locations and contacts
60 sites in 17 countries.
60 sites in 17 countries
United States10 sites
Local Institution - 0095
Austin, Texas, 78731
Local Institution - 0094
Dallas, Texas, 75231
Rocky Mountain Cancer Centers
Denver, Colorado, 80218
Duke Cancer Institute
Durham, North Carolina, 27710
Local Institution - 0090
Houston, Texas, 77030
Broome Oncology
Johnson City, New York, 13790
Local Institution - 0093
Minneapolis, Minnesota, 55404
Local Institution - 0079
Portland, Oregon, 97239
John Wayne Cancer Center
Santa Monica, California, 90404
Texas Oncology - Northeast Texas
Tyler, Texas, 75702
Argentina5 sites
Local Institution - 0078
CABA, 1199
Local Institution - 0015
CABA, 1426
Local Institution - 0016
Ciudad Autonoma Beunos Aires, Buenos Aires, 1431
Local Institution - 0087
Ciudad Autónoma de Buenos Aires, Buenos Aires, 1280
Local Institution - 0119
Córdoba, 5000
France5 sites
Local Institution - 0072
Lyon, 69373
Local Institution - 0075
Marseille, 13273
Local Institution - 0073
Paris, 75248
Local Institution - 0074
Toulouse, 31100
Local Institution - 0085
Villejuif, 94805
Germany5 sites
Local Institution - 0039
Berlin, 12200
Local Institution - 0001
Bonn, 53127
Local Institution - 0002
Dresden, 01307
Local Institution - 0086
Essen, 45147
Local Institution - 0043
Würzburg, 97080
Romania5 sites
Local Institution - 0069
Bucharest, 022328
Local Institution - 0068
Cluj-Napoca, Cluj, 400015
Local Institution - 0067
Craiova, 200542
Local Institution - 0070
Floreşti, 407280
Local Institution - 0071
Timisoara, Timis, 300239
Canada4 sites
Local Institution - 0010
Edmonton, Alberta, T6G 1Z2
Local Institution - 0060
Hamilton, Ontario, L8V 5C2
Local Institution - 0036
Montreal, Quebec, H2X 3E4
Local Institution - 0088
Montreal, Quebec, H3T 1E2
Italy4 sites
Local Institution - 0032
Genova, 16132
IRCCS Istituto Nazionale Tumori Milano
Milan, 20133
Local Institution - 0029
Naples, 80131
Local Institution - 0031
Siena, 53100
Australia3 sites
Local Institution - 0118
St Leonards, New South Wales, 2065
Local Institution - 0062
Sydney, New South Wales, 2010
Local Institution - 0117
Woolloongabba, Queensland, 4102
Belgium3 sites
Local Institution - 0112
Brussels, 1090
Local Institution - 0113
Brussels, 1200
Local Institution - 0114
Leuven, 3000
Spain3 sites
Local Institution - 0084
Barcelona, 08035
Local Institution - 0083
Madrid, 28041
Local Institution - 0110
Pamplona, 31008
Chile2 sites
Local Institution - 0018
Santiago, Santiago Metropolitan, 8330024
Local Institution - 0082
Santiago, Santiago Metropolitan, 8420383
Denmark2 sites
Local Institution - 0080
Copenhagen, 2100
Local Institution - 0081
Herlev, 2730
Netherlands2 sites
Local Institution - 0115
Amsterdam, 1066 CX
Local Institution - 0116
Rotterdam, South Holland, 3015 GD
Poland2 sites
Local Institution - 0077
Gdansk, 80-214
Local Institution - 0076
Warsaw, Masovian Voivodeship, 02-781
Singapore2 sites
Local Institution - 0065
Singapore, Central Singapore, 168583
Local Institution - 0066
Singapore, 117599
United Kingdom2 sites
Local Institution - 0106
London, Greater London, W12 OHS
Local Institution - 0107
Preston, PR2 9HT
About this study
Official title: A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
- Conditions
- Pan Tumor
- Being tested
- Nivolumab, Ipilimumab
- Keywords
- TMB-H
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, BMS-734016
Specified dose on specified days
| Study group | Role | What they receive |
|---|---|---|
| Nivolumab + Ipilimumab Combination | Experimental | Not described Receives: Biological: Nivolumab; Biological: Ipilimumab |
| Nivolumab Monotherapy | Experimental | Not described Receives: Biological: Nivolumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment.
RECIST Criteria:
CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
RANO Criteria:
CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Measured: From date of randomization up to 42 months
Secondary outcomes (13)
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment.
RECIST Criteria:
CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
RANO Criteria:
CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Measured: From date of randomization up to 57 months
Objective Response Rate (ORR) Per Investigator
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on investigator assessment. Calculated using Clopper-Pearson method.
RECIST Criteria:
CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
RANO Criteria:
CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Measured: From date of randomization up to 57 months
Duration of Response (DoR) Per Investigator
DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method.
RECIST Criteria:
CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions.
RANO Criteria:
CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically.
PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Measured: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
DoR was defined as the time from first confirmed complete or partial response to the date of the first documented tumor progression, or death due to any cause, whichever occurs first. Calculated using KM method.
RECIST Criteria:
CR= Disappearance of all target lesions. PR= ≥ 30% decrease in the sum of diameters of target lesions. PD= ≥ 20% increase in the sum of diameters of target lesions.
RANO Criteria:
CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable/improved T2/FLAIR; off corticosteroids; stable/improved clinically PR= ≥ 50% decrease in the sum of diameters of all measurable enhancing lesions; no progression of nonmeasurable disease; no new lesions; stable/improved T2/FLAIR; stable/improved clinically.
PD= ≥ 25% increase in sum of diameters of enhancing lesions, on stable/increasing doses of corticosteroids; significant increase in T2/FLAIR; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Measured: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Time to Objective Response (TTR) Per Investigator
TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on investigator assessment.
RECIST Criteria:
CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
RANO Criteria:
CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Measured: From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
TTR is defined as the time from randomization date to the date of the first confirmed response (complete response (CR) or partial response (PR)), based on Blinded Independent Central Review (BICR) assessment.
RECIST Criteria:
CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm.
PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters.
RANO Criteria:
CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
Measured: From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)
Clinical Benefit Rate (CBR) Per Investigator
CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) based on investigator assessment.
RECIST Criteria:
CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD
RANO Criteria:
CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions
Measured: From date of randomization up to 57 months
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
CBR is defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) or stable disease (SD) per Blinded Independent Central Review (BICR) assessment.
RECIST Criteria:
CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm PR= ≥ 30% decrease in the sum of diameters of target lesions SD= does not qualify for PR or progressive disease
RANO Criteria:
CR= Disappearance of all enhancing disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions; stable or improved clinically SD= does not qualify for CR, PR, or progression; stable nonenhancing T2/FLAIR lesions
Measured: From date of randomization up to 57 months
Progression Free Survival (PFS) Per Investigator
PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by investigator assessment, or death due to any cause, whichever occurs first. Calculated using KM method.
RECIST Criteria:
Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm.
RANO Criteria:
PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Measured: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
PFS is defined as the time from randomization date to the date of the first documented tumor progression, determined by Blinded Independent Central Review (BICR) assessment, or death due to any cause, whichever occurs first. Calculated using KM method.
RECIST Criteria:
Progressive Disease (PD)= ≥ 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. In addition, the sum must also demonstrate an absolute increase of ≥ 5 mm.
RANO Criteria:
PD= ≥ 25% increase in sum of the products of perpendicular diameters of enhancing lesions compared with the smallest tumor measurement obtained either at baseline or best response, on stable or increasing doses of corticosteroids; significant increase in T2/FLAIR nonenhancing lesions on stable or increasing doses of corticosteroids compared with baseline scan or best response after initiation of therapy; any new lesion; clear clinical deterioration or clear progression of nonmeasurable disease.
Measured: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Overall Survival (OS)
OS is defined as the time between the date of randomization and the date of death due to any cause. Participants who did not have a date of death were censored on the last date for which a participant was known to be alive. Calculated using KM method.
Measured: From date of randomization to date of death (Up to 57 months)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Number of participants with any grade adverse events (AEs), serious adverse events (SAEs), drug-related AEs, and drug-related SAEs by Tumor Mutational Burden- High (TMB-H) status using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria. An AE is defined as any new untoward medical occurrence or worsening of a preexisting medical condition in a clinical investigation participant administered study treatment and that does not necessarily have a causal relationship with this treatment.
TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive
Measured: From first dose to 30 days post last dose (Up to 25 months)
Number of Participants With On-Treatment Laboratory Parameters
Number of participants with grade 3-4 on-treatment laboratory parameters. Parameters include hematology, chemistry, liver function, and renal function using worst grade per national cancer institute (NCI) common terminology criteria for adverse events (CTCAE) v5 criteria.
Grade 3=Severe event Grade 4=Life threatening event TMB-H = ≥ 10 mutations per megabase bTMB-H and tTMB-H are not mutually exclusive
Measured: From first dose to 30 days post last dose (Up to 25 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2018
- Study start31 Oct 2018
- Primary completion3 May 2022
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pan TumorStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 212 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bristol-Myers Squibb
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bristol-Myers Squibb, Study director, Bristol-Myers Squibb
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03668119
- Sponsor's protocol ID
- CA209-848
- Other IDs
- 2016-002898-35, 2016
- Acronym
- CheckMate 848
- Status last verified
- Jul 2024
- First submitted
- 11 Sep 2018
- Last updated
- 28 Aug 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Schenker M, Burotto M, Richardet M, Ciuleanu TE, Goncalves A, Steeghs N, Schoffski P, Ascierto PA, Maio M, Lugowska I, Lupinacci L, Leary A, Delord JP, Grasselli J, Tan DSP, Friedmann J, Vuky J, Tschaika M, Konduru S, Vemula SV, Slepetis R, Kollia G, Pacius M, Duong Q, Huang N, Doshi P, Baden J, Di Nicola M. Randomized, open-label, phase 2 study of nivolumab plus ipilimumab or nivolumab monotherapy in patients with advanced or metastatic solid tumors of high tumor mutational burden. J Immunother Cancer. 2024 Aug 6;12(8):e008872. doi: 10.1136/jitc-2024-008872.
PubMed 39107131
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Phase 2 Study of Nivolumab in Combination With Ipilimumab or Nivolumab Monotherapy in Participants With Advanced or Metastatic Solid Tumors of High Tumor Mutational Burden (TMB-H)
- ClinicalTrials.gov ID
- NCT03668119
- Acronym / sponsor ID
- CheckMate 848 / CA209-848
- Conditions
- Pan Tumor
- Keywords
- TMB-H
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 212 participants (actual)
- Lead sponsor
- Bristol-Myers SquibbIndustry (pharma, biotech, devices)
- Study start
- 31 Oct 2018 (actual)
- Primary completion
- 3 May 2022 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 12 Sep 2018 (actual)
- Results
- Posted 18 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to demonstrate the clinical activity of nivolumab in combination with ipilimumab in multiple types of tumors based on their Tumor Mutational Burden status.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Nivolumab + Ipilimumab Combination | Experimental | Biological: Nivolumab, Biological: Ipilimumab |
| Nivolumab Monotherapy | Experimental | Biological: Nivolumab |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Participants with a refractory, metastatic, or unresectable histologically or cytologically confirmed solid malignant tumor with high tumor mutational burden (TMB-H) who are refractory to standard local therapies, or for which no standard treatment is available.
- Must be able to provide tissue and blood TMB-H testing results
- Must have measurable disease for response assessment
Key exclusion criteria (4 listed)
- Participants with melanoma, non-small cell lung cancer (NSCLC), renal cell carcinoma (RCC) or hematological malignancy as primary site of disease
- Participants who received prior treatment with an anti-programmed death-1 (anti-PD-1), anti-programmed death ligand 1 (anti-PD-L1), anti-programmed death ligand 2 (anti-PD-L2), anti-CD137, or anti-cytotoxic T-lymphocyte-associated protein 4 (anti-CTLA-4) antibody, or any other antibody or drug specifically targeting T-cell co-stimulation or checkpoint pathways
- Treatment with any chemotherapy, radiation therapy, biologics for cancer, or investigational therapy within 28 days of first administration of study treatment
- Other protocol defined inclusion/exclusion criteria apply.
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 | Nivolumab + Ipilimumab Combination, Nivolumab Monotherapy |
| IpilimumabAlso: Yervoy, BMS-734016Specified dose on specified days | Biological | Nivolumab + Ipilimumab Combination |
Primary outcome
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A
Time frame: From date of randomization up to 42 months
ORR was defined as the percentage of participants with a best overall response of confirmed complete response (CR) or partial response (PR) based on Blinded Independent Central Review (BICR) assessment. RECIST Criteria: CR= Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to < 10 mm. PR= ≥ 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. RANO Criteria: CR= Disappearance of all enhancing measurable and nonmeasurable disease; stable or improved nonenhancing T2/FLAIR lesions; off corticosteroids; and stable or improved clinically PR= ≥ 50% decrease compared with baseline in the sum of products of perpendicular diameters of all measurable enhancing lesions; no progression of nonmeasureable disease; no new lesions; stable or improved nonenhancing (T2/FLAIR) lesions on same or lower dose of corticosteroids compared with baseline scan; and stable or improved clinically.
13 secondary outcomes
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm B
Time frame: From date of randomization up to 57 months
Objective Response Rate (ORR) Per Investigator
Time frame: From date of randomization up to 57 months
Duration of Response (DoR) Per Investigator
Time frame: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Duration of Response (DoR) Per Blinded Independent Central Review (BICR)
Time frame: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Time to Objective Response (TTR) Per Investigator
Time frame: From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)
Time to Objective Response (TTR) Per Blinded Independent Central Review (BICR)
Time frame: From date of randomization to date of first confirmed response (CR or PR) (Up to 57 months)
Clinical Benefit Rate (CBR) Per Investigator
Time frame: From date of randomization up to 57 months
Clinical Benefit Rate (CBR) Per Blinded Independent Central Review (BICR)
Time frame: From date of randomization up to 57 months
Progression Free Survival (PFS) Per Investigator
Time frame: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Progression Free Survival (PFS) Per Blinded Independent Central Review (BICR)
Time frame: From date of randomization to date of first documented tumor progression, or date of death, whichever occurs first (Up to 57 months)
Overall Survival (OS)
Time frame: From date of randomization to date of death (Up to 57 months)
Number of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: From first dose to 30 days post last dose (Up to 25 months)
Number of Participants With On-Treatment Laboratory Parameters
Time frame: From first dose to 30 days post last dose (Up to 25 months)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39107131Schenker M, Burotto M, Richardet M, Ciuleanu TE, Goncalves A, Steeghs N, Schoffski P, Ascierto PA, Maio M, Lugowska I, Lupinacci L, Leary A, Delord JP, Grasselli J, Tan DSP, Friedmann J, Vuky J, Tschaika M, Konduru S, Vemula SV, Slepetis R, Kollia G, Pacius M, Duong Q, Huang N, Doshi P, Baden J, Di Nicola M. Randomized, open-label, phase 2 study of nivolumab plus ipilimumab or nivolumab monotherapy in patients with advanced or metastatic solid tumors of high tumor mutational burden. J Immunother Cancer. 2024 Aug 6;12(8):e008872. doi: 10.1136/jitc-2024-008872.
- 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.
- Individual participant dataSharing planned: No
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RecruitingPhase 2
Testing the Use of Neratinib or the Combination of Neratinib and Palbociclib Targeted Treatment for HER2+ Solid Tumors (A ComboMATCH Treatment Trial)
Malignant Female Reproductive System Neoplasm, Malignant Solid Neoplasm
RecruitingPhase 1/2
Phase 1/2, Open-label Study of ETX-929, a KRAS Inhibitor in Participants With Advanced Solid Tumors
Metastatic Colorectal Cancer (CRC), Pancreatic Ductal Adenocarcinoma (PDAC)
RecruitingPhase 2
A Clinical Study of Calderasib (MK-1084) in People With Advanced Solid Tumors (MK-1084-014)
Neoplasm Malignant
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
60 sites in 17 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Nivolumab and Ipilimumab in people with Pan Tumor, run by Bristol-Myers Squibb at 60 sites in 17 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 60 sites in United States, Argentina, France, Germany, Romania and 12 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 phase mean?
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?
Yes. Results are posted in the registry (first posted 18 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Objective Response Rate (ORR) Per Blinded Independent Central Review (BICR) - Arm A (time frame: From date of randomization up to 42 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03668119, which also lists 1 linked publication.
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 28 Aug 2024.