Phase 2
Completed N=578
An Investigational Immuno-therapy Study to Investigate the Safety and Effectiveness of Nivolumab, and Nivolumab Combination Therapy in Virus-associated Tumors
Various Advanced Cancer
Source: ClinicalTrials.gov NCT02488759 ↗
Enrolled (actual)
578
Serious AEs
58.5%
Results posted
Apr 2022
Primary outcomePrimary: Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) — 3; 4; 3; 0 Participants
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Neoadjuvant: Number of Participants With Drug-Related Select Adverse Events (AEs) |
3; 4; 3; 0; 0; 9 | — |
| PRIMARY Neoadjuvant: Number of Participants With Drug-Related Serious Adverse Events (SAEs) |
6 | — |
| PRIMARY Neoadjuvant: Rate of Surgery Delay |
0; 0; 7.7; 0; 2.7 | — |
| PRIMARY Metastatic: Investigator-Assessed Objective Response Rate (ORR) |
14.3; 11.5; 31.0; 0; 34.8; 28.6 | — |
| SECONDARY Metastatic: Investigator-Assessed Duration of Response (DoR) |
NA; 44.25; 34.46; 18.23; 3.71; NA | — |
| SECONDARY Metastatic: Overall Survival (OS) |
9.99; 20.44; 17.08; 8.84; 12.12; 14.06 | — |
| SECONDARY Metastatic: Investigator-Assessed Progression-Free Survival (PFS) |
2.94; 3.25; 3.71; 3.81; 4.63; 3.58 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT02488759). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.