Trial · NCT02488759
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
NCT02488759, Phase 1, Phase 2, Completed, Bristol-Myers Squibb; results first posted 2022-04-12
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors. Trials, record NCT02488759. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02488759
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
- NCT number
- NCT02488759
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 578 participants, actual
- Lead sponsor
- Bristol-Myers Squibb
- Conditions
- Various Advanced Cancer
- Interventions
- Nivolumab, Ipilimumab, Relatlimab, Daratumumab
- First posted
- 2015-07-02
- Last updated
- 2023-11-13
- Other registries' IDs
- eudract:2015-000230-29
- Results first posted
- 2022-04-12
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | From first dose to 30 days post last dose (Up to 2 months) | Number of participants with any grade of drug-related select adverse events (AEs) including endocrine, gastrointestinal, hepatic, pulmonary, renal, skin, and hypersensitivity AEs in Neoadjuvant cohort |
| Primary | Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs) | From first dose to 30 days post last dose (Up to 2 months) | Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort |
| Primary | Neoadjuvant: Rate of Surgery Delay | Day 29 | Rate of surgery delay is defined as the percentage of participants in the neoadjuvant cohort with surgery delayed \> 4 weeks from the planned surgery date or planned start date for chemoradiation due to a drug-related adverse event. Participants with the following diseases will be assessed: 1. HPV positive squamous cell carcinoma of the Head and Neck (SCCHN); 2. HPV negative SCCHN; 3. Cervical Carcinoma; 4. Vaginal/Vulvar Carcinoma; 5. Merkel Cell Carcinoma |
| Primary | Metastatic: Investigator-Assessed Objective Response Rate (ORR) | From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 65 months) | Objective response rate (ORR) is defined as the percentage of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) using RECIST 1.1 criteria. An ORR in excess of 10% will be considered of clinical interest, and an ORR of 25% or greater will be considered of strong clinical interest. 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. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) |
| Secondary | Metastatic: Investigator-Assessed Duration of Response (DoR) | From first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months) | Duration of response (DoR) is defined as the time from first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression as determined per investigator assessment using RECIST 1.1 criteria or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) NOTE: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories. |
| Secondary | Metastatic: Overall Survival (OS) | From the first dosing date to the date of death (Up to 83 months) | Overall survival (OS) is defined as the time from first dosing date to the date of death. A participant who has not died will be censored at last known date alive. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories |
| Secondary | Metastatic: Investigator-Assessed Progression-Free Survival (PFS) | From the first dosing date to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months) | Investigator-assessed progression free survival (PFS) is defined as the time from first dosing date to the date of the first documented tumor progression, as determined by investigators (per RECIST 1.1), or death due to any cause, whichever occurs first. Participants with the following diseases will be assessed: 1. EBV positive related gastric cancer; 2. HPV positive SCCHN; 3. Other anogenital HPV associated cancers; 4. GYN (Cervical, Vaginal, Vulvar) carcinoma; 5. Merkel cell carcinoma (MCC); 6. Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories |
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 | Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | From first dose to 30 days post last dose (Up to 2 months) | All treated participants in the neoadjuvant cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs) | From first dose to 30 days post last dose (Up to 2 months) | All treated participants in the neoadjuvant cohort | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Neoadjuvant: Rate of Surgery Delay | Day 29 | All tumor reduction evaluable participants in the neoadjuvant cohort | Percentage of participants | NUMBER |
| PRIMARY | Metastatic: Investigator-Assessed Objective Response Rate (ORR) | From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 65 months) | All treated participants in the metastatic cohorts | Percentage of participants | NUMBER |
| SECONDARY | Metastatic: Investigator-Assessed Duration of Response (DoR) | From first confirmed response (complete response or partial response) to the date of the initial objectively documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months) | All complete and partial responders in the metastatic cohorts | Months | MEDIAN |
| SECONDARY | Metastatic: Overall Survival (OS) | From the first dosing date to the date of death (Up to 83 months) | All treated participants in the metastatic cohorts | Months | MEDIAN |
| SECONDARY | Metastatic: Investigator-Assessed Progression-Free Survival (PFS) | From the first dosing date to the date of the first documented tumor progression or death due to any cause, whichever occurs first (Up to 83 months) | All treated participants in the metastatic cohorts | Months | MEDIAN |
| POST_HOC | Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection | From the date of first dose to the date of the initial objectively documented tumor progression or the date of the last tumor assessment prior to subsequent therapy (Up to 83 months) | All treated participants in the metastatic cohorts | Percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group93
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | Neoadjuvant | Endocrine AEs | 3 | Participants | |
| Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | Neoadjuvant | Gastrointestinal AEs | 4 | Participants | |
| Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | Neoadjuvant | Hepatic AEs | 3 | Participants | |
| Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | Neoadjuvant | Pulmonary AEs | 0 | Participants | |
| Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | Neoadjuvant | Renal AEs | 0 | Participants | |
| Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | Neoadjuvant | Skin AEs | 9 | Participants | |
| Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) | Neoadjuvant | Hypersensitivity/Infusion Reaction AEs | 5 | Participants | |
| Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs) | Neoadjuvant | 6 | Participants | ||
| Neoadjuvant: Rate of Surgery Delay | Neoadjuvant | HPV positive SCCHN | 0 | 95% Confidence Interval 0 to 13.7 | Percentage of participants |
| Neoadjuvant: Rate of Surgery Delay | Neoadjuvant | HPV negative SCCHN | 0 | 95% Confidence Interval 0 to 13.7 | Percentage of participants |
1 to 10 of 93Source ClinicalTrials.gov
See all 93 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Metastatic Monotherapy | 113 | |
| Overall Study | STARTED | Metastatic Combo A | 195 | |
| Overall Study | STARTED | Metastatic Combo B | 133 | |
| Overall Study | STARTED | Metastatic Combo C | 8 | |
| Overall Study | STARTED | Metastatic Combo D | 6 | |
| Overall Study | STARTED | Neoadjuvant | 123 | |
| Overall Study | COMPLETED | Metastatic Monotherapy | 0 | |
| Overall Study | COMPLETED | Metastatic Combo A | 0 | |
| Overall Study | COMPLETED | Metastatic Combo B | 0 | |
| Overall Study | COMPLETED | Metastatic Combo C | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events2,292
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 | Metastatic Monotherapy | 28 | 113 | |
| other | Anaemia | Blood and lymphatic system disorders | Metastatic Combo A | 53 | 195 | |
| other | Anaemia | Blood and lymphatic system disorders | Metastatic Combo B | 42 | 133 | |
| other | Anaemia | Blood and lymphatic system disorders | Metastatic Combo C | 2 | 8 | |
| other | Anaemia | Blood and lymphatic system disorders | Metastatic Combo D | 2 | 6 | |
| other | Anaemia | Blood and lymphatic system disorders | Neoadjuvant | 11 | 123 | |
| other | Ear pain | Ear and labyrinth disorders | Metastatic Monotherapy | 3 | 113 | |
| other | Ear pain | Ear and labyrinth disorders | Metastatic Combo A | 4 | 195 | |
| other | Ear pain | Ear and labyrinth disorders | Metastatic Combo B | 1 | 133 | |
| other | Ear pain | Ear and labyrinth disorders | Metastatic Combo C | 0 | 8 |
1 to 10 of 2,292Source ClinicalTrials.gov
See all 2,292 adverse eventsAdverse event totals18
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Metastatic Monotherapy | 82 | 113 |
| Total, all-cause mortality | Metastatic Combo A | 133 | 195 |
| Total, all-cause mortality | Metastatic Combo B | 86 | 133 |
| Total, all-cause mortality | Metastatic Combo C | 7 | 8 |
| Total, all-cause mortality | Metastatic Combo D | 5 | 6 |
| Total, all-cause mortality | Neoadjuvant | 40 | 123 |
| Total, other adverse events | Metastatic Monotherapy | 110 | 113 |
| Total, other adverse events | Metastatic Combo A | 189 | 195 |
| Total, other adverse events | Metastatic Combo B | 129 | 133 |
| Total, other adverse events | Metastatic Combo C | 7 | 8 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 adverse event totalsPapers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT02488759
GET https://conductscience.org/api/trials/v1/NCT02488759/results?page=2