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Testing the Combination of Two Experimental Drugs MK-3475 (Pembrolizumab) and Interferon-gamma for the Treatment of Mycosis Fungoides and Sézary Syndrome and Advanced Synovial Sarcoma

NCT03063632 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-10-25

Study results available
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Summary

This phase II trial studies how well pembrolizumab and interferon gamma-1b work in treating patients with stage IB-IVB mycosis fungoides and Sezary syndrome that has come back (relapsed) or has not responded to previous treatment (refractory). Immunotherapy with monoclonal antibodies, such as pembrolizumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Interferon gamma-1b may boost the immune system activity. Giving pembrolizumab and interferon gamma-1b together may work better in treating patients with stage IB-IVB mycosis fungoides and Sezary syndrome.

Conditions

  • Metastatic Myxoid Liposarcoma
  • Metastatic Round Cell Liposarcoma
  • Metastatic Synovial Sarcoma
  • Recurrent Mycosis Fungoides and Sezary Syndrome
  • Refractory Mycosis Fungoides and Sezary Syndrome
  • Stage IB Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage II Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage IIA Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage IIB Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage III Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage IIIA Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage IIIB Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage IV Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage IVA Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Stage IVB Mycosis Fungoides and Sezary Syndrome AJCC v7
  • Unresectable Synovial Sarcoma

Interventions

BIOLOGICAL

Interferon Gamma-1b

Given SC

OTHER

Laboratory Biomarker Analysis

Ancillary studies

BIOLOGICAL

Pembrolizumab

Given IV

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    lead NIH

Principal Investigators

  • Michael S Khodadoust, MD · Cancer Immunotherapy Trials Network

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-12-14
Primary Completion
2021-04-08
Completion
2023-03-14
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 NCT03063632 on ClinicalTrials.gov