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Nivolumab or Expectant Observation Following Ipilimumab, Nivolumab, and Surgery in Treating Patients With High Risk Localized, Locoregionally Advanced, or Recurrent Mucosal Melanoma

NCT03220009 · Status: WITHDRAWN · Phase: PHASE2 · Type: INTERVENTIONAL

Last updated 2018-10-03

No results posted yet for this study

Summary

This randomized phase II trial studies how well nivolumab or expectant observation following ipilimumab, nivolumab, and surgery work in treating patients with high-risk mucosal melanoma that is restricted to the site of origin without evidence of spread, has spread to a local and regional area of the body, or has come back. Monoclonal antibodies, such as nivolumab and ipilimumab, may interfere with the ability of tumor cells to grow and spread. Sometimes the mucosal melanoma may not need more treatment until it progresses. In this case, observation may be sufficient. It is not known if nivolumab or expectant observation following ipilimumab, nivolumab, and surgery may be better in treating patients with mucosal melanoma.

Conditions

  • Cervical Carcinoma
  • Esophageal Carcinoma
  • Mucosal Melanoma
  • Mucosal Melanoma of the Head and Neck
  • Oral Cavity Mucosal Melanoma
  • Recurrent Melanoma
  • Stage II Vulvar Cancer AJCC v7
  • Stage III Vulvar Cancer AJCC v7
  • Stage IIIA Vulvar Cancer AJCC v7
  • Stage IIIB Vulvar Cancer AJCC v7
  • Stage IIIC Vulvar Cancer AJCC v7
  • Stage IV Oral Cavity Cancer AJCC v6 and v7
  • Stage IV Vulvar Cancer AJCC v7
  • Stage IVA Oral Cavity Cancer AJCC v6 and v7
  • Stage IVB Oral Cavity Cancer AJCC v6 and v7
  • Stage IVC Oral Cavity Cancer AJCC v6 and v7
  • Vaginal Carcinoma

Interventions

PROCEDURE

Conventional Surgery

Undergo surgery

BIOLOGICAL

Ipilimumab

Given IV

OTHER

Laboratory Biomarker Analysis

Correlative studies

BIOLOGICAL

Nivolumab

Given IV

OTHER

Patient Observation

Undergo active surveillance

RADIATION

Radiation Therapy

Undergo RT

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Alexander Shoushtari · Alliance for Clinical Trials in Oncology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-03
Primary Completion
2021-07-01
Completion
2021-07-01
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03220009 on ClinicalTrials.gov