NCT02488759 · CITED IN SOURCE DOCUMENTS

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

An NCI or FDA source cites this study. A citation does not establish that it applies to an individual diagnosis.

Phase: PHASE1, PHASE2
Status at capture: COMPLETED
Registry last update: 2023-11-13

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

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

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

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outcome · POSTED

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

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outcome · POSTED

Neoadjuvant: Rate of Surgery Delay

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outcome · POSTED

Metastatic: Investigator-Assessed Objective Response Rate (ORR)

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outcome · POSTED

Metastatic: Investigator-Assessed Duration of Response (DoR)

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outcome · POSTED

Metastatic: Overall Survival (OS)

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outcome · POSTED

Metastatic: Investigator-Assessed Progression-Free Survival (PFS)

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outcome · POSTED

Metastatic: Investigator-Assessed Objective Response Rate (ORR) Extended Collection

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: * Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types): 1. Merkel Cell Carcinoma 2. Gastric or Gastro-Esophageal junction carcinoma (No longer enrolling this tumor type) 3. Nasopharyngeal Carcinoma 4. Squamous cell carcinoma (SCC) of the cervix, vagina, or vulva 5. Squamous cell carcinoma of the Head and Neck 6. Squamous cell carcinoma of the anal canal and penis 7. 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 * Measurable disease by CT or MRI * Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 * Patient willing to comply to provide tumor tissue (archival or fresh biopsy specimen) * Men and women of age 18 or older Exclusion Criteria: * Active brain metastases or leptomeningeal metastases * Patients with active, known or suspected autoimmune disease * Patients with a condition requiring systemic treatment with either corticosteroids or other immunosuppressive medications * Patients with hepatitis * Patients with HIV * Pregnant or breastfeeding women
healthy Volunteers: false
minimum Age: 18 Years
sex: ALL
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Nivolumab intravenous infusion as specified \*\*Not participating: Japan, Korea, and Taiwan
intervention Names
Drug: Nivolumab
label
Neoadjuvant Cohort
type
EXPERIMENTAL
description
Nivolumab intravenous infusion as specified
intervention Names
Drug: Nivolumab
label
Metastatic Monotherapy Cohort
type
EXPERIMENTAL
description
Nivolumab intravenous infusion as specified with Ipilimumab intravenous infusion as specified \*\*Not participating: Belgium, France and Germany Cohort expansion participating countries: Spain, US, UK, Netherlands, Japan and Mexico \*\*Not participating in cohort expansion: France, Germany, Korea and Taiwan
intervention Names
Drug: Nivolumab
Drug: Ipilimumab
label
Nivolumab plus Ipilimumab Cohort
type
EXPERIMENTAL
description
Nivolumab intravenous infusion as specified with Relatlimab intravenous infusion as specified \*\* Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort
intervention Names
Drug: Nivolumab
Drug: Relatlimab
label
Nivolumab plus Relatlimab Cohort
type
EXPERIMENTAL
description
Nivolumab intravenous infusion as specified with Daratumumab intravenous infusion as specified \*\*Not Participating: Belgium, Germany, France, Japan, Korea, Taiwan, UK, and Netherlands Enrollment is closed for this cohort
intervention Names
Drug: Nivolumab
Drug: Daratumumab
label
Nivolumab plus Daratumumab Cohort
type
EXPERIMENTAL

interventions

arm Group Labels
Metastatic Monotherapy Cohort
Neoadjuvant Cohort
Nivolumab plus Daratumumab Cohort
Nivolumab plus Ipilimumab Cohort
Nivolumab plus Relatlimab Cohort
name
Nivolumab
type
DRUG
arm Group Labels
Nivolumab plus Ipilimumab Cohort
name
Ipilimumab
type
DRUG
arm Group Labels
Nivolumab plus Relatlimab Cohort
name
Relatlimab
other Names
BMS-986016
Anti-LAG 3
type
DRUG
arm Group Labels
Nivolumab plus Daratumumab Cohort
name
Daratumumab
other Names
Darzalex
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

TREATMENT

Enrollment

count: 578
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
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
measure
Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)
time Frame
From first dose to 30 days post last dose (Up to 2 months)
description
Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort
measure
Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)
time Frame
From first dose to 30 days post last dose (Up to 2 months)
description
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
measure
Neoadjuvant: Rate of Surgery Delay
time Frame
Day 29
description
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)
measure
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
time Frame
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)

secondary Outcomes

description
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.
measure
Metastatic: Investigator-Assessed Duration of Response (DoR)
time Frame
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)
description
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
measure
Metastatic: Overall Survival (OS)
time Frame
From the first dosing date to the date of death (Up to 83 months)
description
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
measure
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
time Frame
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)

Full study description

brief 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

Source references

references

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