CompletedPhase 1/2

An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors

United States, Belgium, France578 participantsStarted 2015-10-13

Plain-language summary

The purpose of this study to investigate the safety and effectiveness of nivolumab, and nivolumab combination therapy, to treat patients who have virus-associated tumors. Certain viruses have been known to play a role in tumor formation and growth. This study will investigate the effects of the study drugs, in patients who have the following types of tumors: * Anal canal cancer-No longer enrolling this tumor type * Cervical cancer * Epstein Barr Virus (EBV) positive gastric cancer-No longer enrolling this tumor type * Merkel Cell Cancer * Penile cancer-No longer enrolling this tumor type * Vaginal and vulvar cancer-No longer enrolling this tumor type * Nasopharyngeal Cancer - No longer enrolling this tumor type * Head and Neck Cancer - No longer enrolling this tumor type

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Merkel Cell Carcinoma
. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type)
. Nasopharyngeal Carcinoma
. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva
. Squamous cell carcinoma of the Head and Neck
. Squamous cell carcinoma of the anal canal and penis
. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)

Timeframe: From first dose to 30 days post last dose (Up to 2 months)

Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)

Timeframe: From first dose to 30 days post last dose (Up to 2 months)

Neoadjuvant: Rate of Surgery Delay

Timeframe: Day 29

Metastatic: Investigator-Assessed Objective Response Rate (ORR)

Timeframe: 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)

Trial details

NCT IDNCT02488759

SponsorBristol-Myers Squibb

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-03-19

Results submitted2022-03-17

View on ClinicalTrials.gov More Various Advanced Cancer trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Merkel Cell Carcinoma
. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type)
. Nasopharyngeal Carcinoma
. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva
. Squamous cell carcinoma of the Head and Neck
. Squamous cell carcinoma of the anal canal and penis
. Recurrent/metastatic SCC of the cervix not amenable to curative treatment with surgery and/or radiation therapy who are unsuitable for platinum-based therapy may enroll in the cervical cancer Combination B expansion cohort

What they're measuring

Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)

Timeframe: From first dose to 30 days post last dose (Up to 2 months)

Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)

Timeframe: From first dose to 30 days post last dose (Up to 2 months)

Neoadjuvant: Rate of Surgery Delay

Timeframe: Day 29

Metastatic: Investigator-Assessed Objective Response Rate (ORR)

Timeframe: 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)