Trial · NCT02741570
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
NCT02741570, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2022-05-03
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck. Trials, record NCT02741570. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02741570
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
Study of Nivolumab in Combination With Ipilimumab Compared to the Standard of Care (Extreme Regimen) as First Line Treatment in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck
- NCT number
- NCT02741570
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 947 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Head and Neck Cancer
- Interventions
- Nivolumab, Ipilimumab, Cetuximab/Erbitux, Cisplatin/Platinol, Carboplatin/Paraplatin, Fluorouracil/Adrucil
- First posted
- 2016-04-18
- Last updated
- 2023-09-21
- Other registries' IDs
- eudract:2016-000725-39
- Results first posted
- 2022-05-03
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 | From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months) | Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) |
| Primary | Overall Survival (OS) in All Randomized Participants | From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months) | Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) |
| Secondary | Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1 | From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months) | Overall survival (OS) is defined as the time between randomization and death. For participants without documentation of death, OS will be censored on the last date the participant was known to be alive. Overall survival will be censored at the date of randomization for participants who were randomized but had no follow-up. Survival follow-up will be conducted every 3 months after participants off-treatment date. (Based on Kaplan-Meier estimates) |
| Secondary | Progression Free Survival (PFS) | From randomization to disease progression or death (Up to approximately 65 months) | PFS is defined as the time between the date of randomization and the date of first documented tumor progression, based on Blinded Independent Central Review (BICR) assessments (per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria), or death due to any cause, whichever occurs first. Participants who neither progress nor die will be censored on the date of their last tumor assessment. Participants who receive subsequent anti-cancer therapy prior to documented progression, will be censored on the date of their last tumor assessment prior to subsequent therapy. (Based on Kaplan-Meier Estimates) Progression is defined as at least a 20% increase in the sum of diameters of target lesions, in addition the sum must also demonstrate an absolute increase of at least 5 mm. (Note: the appearance of one or more new lesions is also considered progression). |
| Secondary | Objective Response Rate (ORR) | From randomization up to approximately 65 months | Objective Response Rate (ORR) is defined as the number of participants with a best overall response (BOR) of complete response (CR) or partial response (PR). Based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria by blinded independent central review (BICR) assessment. Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
| Secondary | Duration of Objective Response (DOR) | From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months) | The time between the first documented response (Complete response (CR) or partial response (PR)) and progression or death, per RECIST 1.1 by blinded independent central review (BICR) assessment. (Based on Kaplan-Meier Estimates) Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \< 10 mm. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 | From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months) | All randomized PD-L1 CPS \>= 20 participants | Months | MEDIAN |
| PRIMARY | Overall Survival (OS) in All Randomized Participants | From randomization to date of death or date the participant was last known to be alive (Up to approximately 55 months) | All randomized participants | Months | MEDIAN |
| SECONDARY | Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1 | From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months) | All randomized PD-L1 CPS ≥ 1 participants | Months | MEDIAN |
| SECONDARY | Progression Free Survival (PFS) | From randomization to disease progression or death (Up to approximately 65 months) | All randomized participants and randomized PD-L1 CPS \>= 20 participants | Months | MEDIAN |
| SECONDARY | Objective Response Rate (ORR) | From randomization up to approximately 65 months | All randomized participants and randomized PD-L1 CPS \>= 20 participants | Percent | NUMBER |
| SECONDARY | Duration of Objective Response (DOR) | From randomization to the first documented response (CR or PR) and progression (up to approximately 65 months) | All randomized participants and randomized PD-L1 CPS \>= 20 participants with a BOR response of CR or PR | Months | MEDIAN |
| POST_HOC | Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 - Extended Collection | From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months) | All randomized PD-L1 CPS \>= 20 participants | Months | MEDIAN |
| POST_HOC | Overall Survival (OS) in All Randomized Participants - Extended Collection | From randomization to date of death or date the participant was last known to be alive (Up to approximately 65 months) | All randomized participants | Months | MEDIAN |
Source ClinicalTrials.gov
Results by group22
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 | Nivolumab + Ipilimumab | 17.58 | 95% Confidence Interval 13.77 to 21.98 | Months | |
| Overall Survival (OS) in Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥20 | EXTREME Regimen | 14.59 | 95% Confidence Interval 12.32 to 15.97 | Months | |
| Overall Survival (OS) in All Randomized Participants | Nivolumab + Ipilimumab | 13.90 | 95% Confidence Interval 12.12 to 15.77 | Months | |
| Overall Survival (OS) in All Randomized Participants | EXTREME Regimen | 13.50 | 95% Confidence Interval 12.55 to 15.21 | Months | |
| Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1 | Nivolumab + Ipilimumab | 15.67 | 95% Confidence Interval 13.70 to 18.79 | Months | |
| Overall Survival (OS) in Randomized Participants With Programmed Death-Ligand 1 (PD-L1) With a Combined Positive Score (CPS) ≥ 1 | EXTREME Regimen | 13.24 | 95% Confidence Interval 11.07 to 14.59 | Months | |
| Progression Free Survival (PFS) | Nivolumab + Ipilimumab | Randomized participants | 3.29 | 95% Confidence Interval 2.83 to 4.17 | Months |
| Progression Free Survival (PFS) | EXTREME Regimen | Randomized participants | 6.77 | 95% Confidence Interval 5.78 to 7.00 | Months |
| Progression Free Survival (PFS) | Nivolumab + Ipilimumab | Randomized PD-L1 CPS >= 20 participants | 5.39 | 95% Confidence Interval 3.09 to 6.93 | Months |
| Progression Free Survival (PFS) | EXTREME Regimen | Randomized PD-L1 CPS >= 20 participants | 6.97 | 95% Confidence Interval 5.78 to 8.67 | Months |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Pre-Treatment Period | STARTED | Nivolumab + Ipilimumab | 472 | |
| Pre-Treatment Period | STARTED | EXTREME Regimen | 475 | |
| Pre-Treatment Period | COMPLETED | Nivolumab + Ipilimumab | 468 | |
| Pre-Treatment Period | COMPLETED | EXTREME Regimen | 441 | |
| Pre-Treatment Period | NOT COMPLETED | Nivolumab + Ipilimumab | 4 | |
| Pre-Treatment Period | NOT COMPLETED | EXTREME Regimen | 34 | |
| Treatment Period | STARTED | Nivolumab + Ipilimumab | 468 | |
| Treatment Period | STARTED | EXTREME Regimen | 441 | |
| Treatment Period | COMPLETED | Nivolumab + Ipilimumab | 0 | |
| Treatment Period | COMPLETED | EXTREME Regimen | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events892
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Anaemia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 102 | 468 | |
| other | Anaemia | Blood and lymphatic system disorders | EXTREME Regimen | 190 | 441 | |
| other | Leukopenia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 6 | 468 | |
| other | Leukopenia | Blood and lymphatic system disorders | EXTREME Regimen | 35 | 441 | |
| other | Lymphopenia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 17 | 468 | |
| other | Lymphopenia | Blood and lymphatic system disorders | EXTREME Regimen | 25 | 441 | |
| other | Neutropenia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 11 | 468 | |
| other | Neutropenia | Blood and lymphatic system disorders | EXTREME Regimen | 131 | 441 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | Nivolumab + Ipilimumab | 7 | 468 | |
| other | Thrombocytopenia | Blood and lymphatic system disorders | EXTREME Regimen | 109 | 441 |
1 to 10 of 892Source ClinicalTrials.gov
See all 892 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Nivolumab + Ipilimumab | 388 | 472 |
| Total, all-cause mortality | EXTREME Regimen | 406 | 475 |
| Total, other adverse events | Nivolumab + Ipilimumab | 420 | 468 |
| Total, other adverse events | EXTREME Regimen | 429 | 441 |
| Total, serious adverse events | Nivolumab + Ipilimumab | 313 | 468 |
| Total, serious adverse events | EXTREME Regimen | 290 | 441 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Nivolumab + Ipilimumab vs EXTREME Regimen: deaths from any cause | Trial comparisons |
| Nivolumab + Ipilimumab vs EXTREME Regimen: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02741570
GET https://conductscience.org/api/trials/v1/NCT02741570/results?page=2