An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (CheckMate358)

December 12, 2022 updated by: Bristol-Myers Squibb

Non-Comparative, Open-Label, Multiple Cohort, Phase 1/2 Study of Nivolumab Monotherapy and Nivolumab Combination Therapy in Subjects With Virus-Positive and Virus-Negative Solid Tumors

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

578

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Brussels, Belgium, 1000
        • Local Institution - 0012
      • Brussels, Belgium, 1090
        • Local Institution - 0014
      • Bruxelles, Belgium, 1200
        • Local Institution - 0013
  • France
      • Marseille Cedex 9, France, 13273
        • Local Institution - 0031
      • Paris, France, 75475
        • Local Institution - 0038
      • Toulouse Cedex 9, France, 31059
        • Local Institution - 0032
      • Vlllejuif, France, 94800
        • Local Institution - 0030
  • Germany
      • Essen, Germany, 45147
        • Local Institution - 0027
      • Heilbronn, Germany, 74078
        • Local Institution - 0028
  • Japan
    • Chiba
      • Kashiwa-shi, Chiba, Japan, 2778577
        • Local Institution - 0039
    • Tokyo
      • Chuo-ku, Tokyo, Japan, 1040045
        • Local Institution - 0040
      • Koto-ku, Tokyo, Japan, 135-8550
        • Local Institution - 0041
  • Korea, Republic of
      • Seoul, Korea, Republic of, 03080
        • Local Institution - 0024
  • Mexico
    • Distrito Federal
      • Mexico City, Distrito Federal, Mexico, 04700
        • Local Institution - 0056
    • Oaxaca
      • Oaxaca de Juarez, Oaxaca, Mexico, 68040
        • Local Institution
    • Yucatan
      • Merida, Yucatan, Mexico, 97138
        • Local Institution - 0046
  • Netherlands
      • Amsterdam, Netherlands, 1066 CX
        • Local Institution - 0011
      • Utrecht, Netherlands, 3584CX
        • Local Institution - 0034
  • Spain
      • Barcelona, Spain, 08035
        • Local Institution - 0018
      • Madrid, Spain, 28050
        • Local Institution - 0017
      • Navarra, Spain, 31008
        • Local Institution - 0016
  • Taiwan
      • Tainan, Taiwan, 70403
        • Local Institution - 0037
      • Taipei, Taiwan, 10002
        • Local Institution - 0026
  • United Kingdom
      • London, United Kingdom, W1T 7HA
        • Local Institution - 0008
    • Lanarkshire
      • Glasgow, Lanarkshire, United Kingdom, G12 OYN
        • Local Institution - 0006
    • West Midlands
      • Birmingham, West Midlands, United Kingdom, B15 2TH
        • Local Institution - 0010
  • United States
    • Florida
      • Tampa, Florida, United States, 33612-9497
        • Local Institution - 0033
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Local Institution - 0003
    • Maryland
      • Lutherville, Maryland, United States, 21093
        • Local Institution - 0023
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0002
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0019
      • Boston, Massachusetts, United States, 02114
        • Local Institution - 0020
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • Local Institution - 0035
    • New York
      • New York, New York, United States, 10065
        • Local Institution - 0036
    • North Carolina
      • Charlotte, North Carolina, United States, 28204
        • Local Institution - 0022
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73104
        • Local Institution - 0005
    • Oregon
      • Portland, Oregon, United States, 97213
        • Local Institution - 0004
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15232
        • Local Institution - 0029
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57104
        • Local Institution - 0001
    • Washington
      • Seattle, Washington, United States, 98109
        • Local Institution - 0021

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Neoadjuvant Cohort

Nivolumab intravenous infusion as specified

**Not participating: Japan, Korea, and Taiwan
Drug: Nivolumab
Experimental: Metastatic Monotherapy Cohort
Nivolumab intravenous infusion as specified
Drug: Nivolumab
Experimental: Nivolumab plus Ipilimumab Cohort

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
Drug: Ipilimumab
Drug: Nivolumab
Experimental: Nivolumab plus Relatlimab Cohort

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
Drug: Nivolumab
Drug: Relatlimab
Other Names:
  • BMS-986016
  • Anti-LAG 3
Experimental: Nivolumab plus Daratumumab Cohort

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
Drug: Nivolumab
Drug: Daratumumab
Other Names:
  • Darzalex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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
From first dose to 30 days post last dose (Up to 2 months)
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)
Number of participants with any grade of drug-related serious adverse events (SAEs) in Neoadjuvant cohort
From first dose to 30 days post last dose (Up to 2 months)
Neoadjuvant: Rate of Surgery Delay
Time Frame: 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
Day 29
Metastatic: Investigator-Assessed Objective Response Rate (ORR)
Time Frame: Up to 72 months

Objective response rate (ORR) is defined as the the number of participants with a best overall response (BOR) of confirmed complete response (CR) or partial response (PR) divided by the number of treated participants 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)
Up to 72 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Metastatic: Investigator-Assessed Duration of Response (DoR)
Time Frame: Up to 72 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)
Up to 72 months
Metastatic: Overall Survival (OS)
Time Frame: Up to 72 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)
Up to 72 months
Metastatic: Investigator-Assessed Progression-Free Survival (PFS)
Time Frame: Up to 72 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. 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)
Up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bristol-Myers Squibb

Collaborators

Ono Pharmaceutical Co. Ltd

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 13, 2015

Primary Completion (Actual)

March 19, 2021

Study Completion (Actual)

October 24, 2022

Study Registration Dates

First Submitted

June 30, 2015

First Submitted That Met QC Criteria

June 30, 2015

First Posted (Estimate)

July 2, 2015

Study Record Updates

Last Update Posted (Estimate)

December 13, 2022

Last Update Submitted That Met QC Criteria

December 12, 2022

Last Verified

November 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CA209-358
  • 2015-000230-29 (EudraCT Number)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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