Trial · NCT02105636

Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)

NCT02105636, Phase 3, Completed, Bristol-Myers Squibb; results first posted 2017-01-11

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141). Trials, record NCT02105636. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02105636

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Trial of Nivolumab vs Therapy of Investigator's Choice in Recurrent or Metastatic Head and Neck Carcinoma (CheckMate 141)
NCT number: NCT02105636
Status: Completed
Phases: Phase 3
Enrollment: 361 participants, actual
Lead sponsor: Bristol-Myers Squibb
Conditions: Squamous Cell Carcinoma of the Head and Neck
Interventions: Nivolumab, Cetuximab, Methotrexate, Docetaxel
First posted: 2014-04-07
Last updated: 2022-10-05
Other registries' IDs: eudract:2013-003622-86
Results first posted: 2017-01-11

Source ClinicalTrials.gov

Registered outcomes3

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Overall Survival (OS)	From date of randomization to date of death (Up to approximately 18 months)	OS was defined as the time from randomization to the date of death from any cause. Participants were censored at the date they were last known to be alive and at the date of randomization if they were randomized but had no follow-up. Median OS time was calculated using Kaplan-Meier (KM) method.
Secondary	Investigator-Assessed Progression-Free Survival (PFS)	From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)	PFS was defined as the time between the date of randomization and the first date of documented progression, as determined by the investigator (as per Response Evaluation Criteria In Solid Tumors (RECIST1.1)), or death due to any cause, whichever occurs first. Progressive Disease: at least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. The sum must demonstrate an absolute increase of at least 5mm. Participants who: * Die without a reported progression were considered to have progressed on the date of their death. * Did not progress or die were censored on the date of their last evaluable tumor assessment. * Without any on study tumor assessments and did not die were censored on their date of randomization. * Received subsequent systemic anti-cancer therapy prior to documented progression were censored at the date of the last tumor assessment prior to the initiation of the new therapy.
Secondary	Investigator-Assessed Objective Response Rate (ORR)	From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)	ORR was defined as the percentage of randomized participants who achieved a best response of complete response (CR) or partial response (PR) using the RECIST1.1 criteria as per investigator assessment. Complete Response (CR): Disappearance of all target lesions. Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Survival (OS)	From date of randomization to date of death (Up to approximately 18 months)	All randomized participants	Months	MEDIAN
SECONDARY	Investigator-Assessed Progression-Free Survival (PFS)	From date of randomization to date of disease progression or death, whichever occurs first (Up to approximately 87 months)	All randomized participants	Months	MEDIAN
SECONDARY	Investigator-Assessed Objective Response Rate (ORR)	From date of randomization to date of disease progression or study drug is discontinued, whichever occurs first (Up to approximately 87 months)	All randomized participants	Percentage of Participants	NUMBER
POST_HOC	Overall Survival (OS) - Extended Collection	From date of randomization to date of death (Up to approximately 87 months)	All randomized participants	Months	MEDIAN

Source ClinicalTrials.gov

Results by group8

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Overall Survival (OS)	Nivolumab 3mg/kg	7.49	95% Confidence Interval 5.49 to 9.10	Months
Overall Survival (OS)	Investigators Choice	5.06	95% Confidence Interval 4.04 to 6.05	Months
Investigator-Assessed Progression-Free Survival (PFS)	Nivolumab 3mg/kg	2.04	95% Confidence Interval 1.91 to 2.14	Months
Investigator-Assessed Progression-Free Survival (PFS)	Investigators Choice	2.33	95% Confidence Interval 1.94 to 3.06	Months
Investigator-Assessed Objective Response Rate (ORR)	Nivolumab 3mg/kg	13.3	95% Confidence Interval 9.3 to 18.3	Percentage of Participants
Investigator-Assessed Objective Response Rate (ORR)	Investigators Choice	5.8	95% Confidence Interval 2.4 to 11.6	Percentage of Participants
Overall Survival (OS) - Extended Collection	Nivolumab 3mg/kg	7.72	95% Confidence Interval 5.68 to 8.74	Months
Overall Survival (OS) - Extended Collection	Investigators Choice	5.06	95% Confidence Interval 4.04 to 6.24	Months

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Pre-Treatment	STARTED	Nivolumab 3mg/kg	240
Pre-Treatment	STARTED	Investigators Choice	121
Pre-Treatment	COMPLETED	Nivolumab 3mg/kg	236
Pre-Treatment	COMPLETED	Investigators Choice	111
Pre-Treatment	NOT COMPLETED	Nivolumab 3mg/kg	4
Pre-Treatment	NOT COMPLETED	Investigators Choice	10
Treatment	STARTED	Nivolumab 3mg/kg	236
Treatment	STARTED	Investigators Choice	111
Treatment	COMPLETED	Nivolumab 3mg/kg	1
Treatment	COMPLETED	Investigators Choice	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events486

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
other	Anaemia	Blood and lymphatic system disorders	Nivolumab 3mg/kg	53	236
other	Anaemia	Blood and lymphatic system disorders	Investigator Choice	42	111
other	Neutropenia	Blood and lymphatic system disorders	Nivolumab 3mg/kg	2	236
other	Neutropenia	Blood and lymphatic system disorders	Investigator Choice	9	111
other	Thrombocytopenia	Blood and lymphatic system disorders	Nivolumab 3mg/kg	4	236
other	Thrombocytopenia	Blood and lymphatic system disorders	Investigator Choice	6	111
other	Tachycardia	Cardiac disorders	Nivolumab 3mg/kg	7	236
other	Tachycardia	Cardiac disorders	Investigator Choice	7	111
other	Hypothyroidism	Endocrine disorders	Nivolumab 3mg/kg	21	236
other	Hypothyroidism	Endocrine disorders	Investigator Choice	7	111

1 to 10 of 486Source ClinicalTrials.gov

See all 486 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Nivolumab 3mg/kg	220	240
Total, all-cause mortality	Investigator Choice	119	121
Total, other adverse events	Nivolumab 3mg/kg	210	236
Total, other adverse events	Investigator Choice	108	111
Total, serious adverse events	Nivolumab 3mg/kg	165	236
Total, serious adverse events	Investigator Choice	87	111

Source ClinicalTrials.gov

Papers8

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
27718784	DERIVED	PubMed
28651929	DERIVED	PubMed
28939066	DERIVED	PubMed
29884413	DERIVED	PubMed
30944020	DERIVED	PubMed
30972702	DERIVED	PubMed
31422216	DERIVED	PubMed
32583557	DERIVED	PubMed

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 3mg/kg vs Investigator Choice: deaths from any cause	Trial comparisons
Nivolumab 3mg/kg vs Investigator Choice: 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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT02105636

GET https://conductscience.org/api/trials/v1/NCT02105636/events?page=2

API reference For AI assistants