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

Various Advanced Cancer Clinical Trial

— CheckMate358  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02488759
• Other study ID #: CA209-358
• Secondary ID: 2015-000230-29
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: October 13, 2015
• Est. completion date: October 24, 2022

Study information

• Verified date: November 2023
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 578
• Est. completion date: October 24, 2022
• Est. primary completion date: March 19, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Various Advanced Cancer

Intervention

Drug:
• Nivolumab

• Ipilimumab

• Relatlimab

• Daratumumab

Locations

Country	Name	City	State
Belgium	Local Institution - 0012	Brussels
Belgium	Local Institution - 0014	Brussels
Belgium	Local Institution - 0013	Bruxelles
France	Local Institution - 0031	Marseille Cedex 9
France	Local Institution - 0038	Paris
France	Local Institution - 0032	Toulouse Cedex 9
France	Local Institution - 0030	Vlllejuif
Germany	Local Institution - 0027	Essen
Germany	Local Institution - 0028	Heilbronn
Japan	Local Institution - 0040	Chuo-ku	Tokyo
Japan	Local Institution - 0039	Kashiwa-shi	Chiba
Japan	Local Institution - 0041	Koto-ku	Tokyo
Korea, Republic of	Local Institution - 0024	Seoul
Mexico	Local Institution - 0046	Merida	Yucatan
Mexico	Local Institution - 0056	Mexico City	Distrito Federal
Mexico	Local Institution	Oaxaca de Juarez	Oaxaca
Netherlands	Local Institution - 0011	Amsterdam
Netherlands	Local Institution - 0034	Utrecht
Spain	Local Institution - 0018	Barcelona
Spain	Local Institution - 0017	Madrid
Spain	Local Institution - 0016	Navarra
Taiwan	Local Institution - 0037	Tainan
Taiwan	Local Institution - 0026	Taipei
United Kingdom	Local Institution - 0010	Birmingham	West Midlands
United Kingdom	Local Institution - 0006	Glasgow	Lanarkshire
United Kingdom	Local Institution - 0008	London
United States	Local Institution - 0035	Ann Arbor	Michigan
United States	Local Institution - 0003	Atlanta	Georgia
United States	Local Institution - 0002	Boston	Massachusetts
United States	Local Institution - 0019	Boston	Massachusetts
United States	Local Institution - 0020	Boston	Massachusetts
United States	Local Institution - 0022	Charlotte	North Carolina
United States	Local Institution - 0023	Lutherville	Maryland
United States	Local Institution - 0036	New York	New York
United States	Local Institution - 0005	Oklahoma City	Oklahoma
United States	Local Institution - 0029	Pittsburgh	Pennsylvania
United States	Local Institution - 0004	Portland	Oregon
United States	Local Institution - 0021	Seattle	Washington
United States	Local Institution - 0001	Sioux Falls	South Dakota
United States	Local Institution - 0033	Tampa	Florida

Sponsors (2)

Lead Sponsor	Collaborator
Bristol-Myers Squibb	Ono Pharmaceutical Co. Ltd

Countries where clinical trial is conducted

United States,  Belgium,  France,  Germany,  Japan,  Korea, Republic of,  Mexico,  Netherlands,  Spain,  Taiwan,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs)	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)
Primary	Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs)	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)
Primary	Neoadjuvant: Rate of Surgery Delay	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	Day 29
Primary	Metastatic: Investigator-Assessed Objective Response Rate (ORR)	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)	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	Metastatic: Investigator-Assessed Duration of Response (DoR)	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.	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)
Secondary	Metastatic: Overall Survival (OS)	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	From the first dosing date to the date of death (Up to 83 months)
Secondary	Metastatic: Investigator-Assessed Progression-Free Survival (PFS)	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	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)

External Links

•   BMS Clinical Trial Information
•   BMS Clinical Trial Patient Recruiting
•   FDA Safety Alerts and Recalls
•   Investigator Inquiry Form