An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors (CheckMate358)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT02488759 |
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Recruitment Status :
Completed
First Posted : July 2, 2015
Results First Posted : April 12, 2022
Last Update Posted : November 13, 2023
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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
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Various Advanced Cancer | Drug: Nivolumab Drug: Ipilimumab Drug: Relatlimab Drug: Daratumumab | Phase 1 Phase 2 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 578 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | 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 |
| Actual Study Start Date : | October 13, 2015 |
| Actual Primary Completion Date : | March 19, 2021 |
| Actual Study Completion Date : | October 24, 2022 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Neoadjuvant Cohort
Nivolumab intravenous infusion as specified **Not participating: Japan, Korea, and Taiwan |
Drug: Nivolumab |
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Experimental: Metastatic Monotherapy Cohort
Nivolumab intravenous infusion as specified
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Drug: Nivolumab |
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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: Nivolumab Drug: Ipilimumab |
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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:
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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 Name: Darzalex |
- 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
- 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
- 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.
Participants with the following diseases will be assessed:
- HPV positive squamous cell carcinoma of the Head and Neck (SCCHN);
- HPV negative SCCHN;
- Cervical Carcinoma;
- Vaginal/Vulvar Carcinoma;
- Merkel Cell Carcinoma
- 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) ]
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:
- EBV positive related gastric cancer;
- HPV positive SCCHN;
- Other anogenital HPV associated cancers;
- GYN (Cervical, Vaginal, Vulvar) carcinoma;
- Merkel cell carcinoma (MCC);
- Nasopharyngeal carcinoma (NPC)
- 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) ]
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:
- EBV positive related gastric cancer;
- HPV positive SCCHN;
- Other anogenital HPV associated cancers;
- GYN (Cervical, Vaginal, Vulvar) carcinoma;
- Merkel cell carcinoma (MCC);
- Nasopharyngeal carcinoma (NPC) NOTE: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories.
- Metastatic: Overall Survival (OS) [ Time Frame: 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:
- EBV positive related gastric cancer;
- HPV positive SCCHN;
- Other anogenital HPV associated cancers;
- GYN (Cervical, Vaginal, Vulvar) carcinoma;
- Merkel cell carcinoma (MCC);
- Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
- 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) ]
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:
- EBV positive related gastric cancer;
- HPV positive SCCHN;
- Other anogenital HPV associated cancers;
- GYN (Cervical, Vaginal, Vulvar) carcinoma;
- Merkel cell carcinoma (MCC);
- Nasopharyngeal carcinoma (NPC) Note: "Cervical, Randomized" and "Cervical, Pooled" are not mutually exclusive categories
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
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Histopathologic confirmation of the following tumor types (please refer to protocol for full details pertaining to eligible tumor types):
- 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
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02488759
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| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
Documents provided by Bristol-Myers Squibb:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT02488759 |
| Other Study ID Numbers: |
CA209-358 2015-000230-29 ( EudraCT Number ) |
| First Posted: | July 2, 2015 Key Record Dates |
| Results First Posted: | April 12, 2022 |
| Last Update Posted: | November 13, 2023 |
| Last Verified: | November 2023 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Nivolumab Ipilimumab Relatlimab Daratumumab |
Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |