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Completed

NCT Number: NCT02488759

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

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Key information

Conditions

Various Advanced Cancer

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Local Institution - 0012, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Treatment and study plan

Nivolumab

Drug

Ipilimumab

Drug

Relatlimab

Drug

Other names: BMS-986016, Anti-LAG 3

Daratumumab

Drug

Other names: Darzalex

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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)

Secondary outcomes

  1. 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.

  2. 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

  3. 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

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Collaborators

  • Ono Pharmaceutical Co., Ltd.

Registry information

Official study 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

Acronym: CheckMate358

Important dates

Study start
2015
Primary completion
2021
Study completion
2022
First posted
Jul 2, 2015
Registry last updated
Nov 13, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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