Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma

Part of paid clinical trials in Chicago, Illinois.

Sponsor
Northwestern University
Study ID
NCT07050186
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic NUT Carcinoma
  • Unresectable NUT Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Biopsy Procedure — PROCEDURE
    Undergo optional biopsy
  • Biospecimen Collection — PROCEDURE
    Undergo collection of blood samples
  • Cemiplimab — BIOLOGICAL
    Given IV
  • Computed Tomography — PROCEDURE
    Undergo CT
  • Digital Photography — OTHER
    Undergo digital photography
  • Magnetic Resonance Imaging — PROCEDURE
    Undergo MRI
  • Questionnaire Administration — OTHER
    Ancillary studies

Study Details

This phase II trial studies how well cemiplimab works in treating patients with nuclear protein of testis (NUT) carcinoma for which no treatment is currently available (incurable) and that has spread from where it first started (primary site) to other places in the body (metastatic) or cannot be removed by surgery (resectable). Immunotherapy with monoclonal antibodies, such as cemiplimab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread.

Key Dates

Start date
Aug 15, 2025
Status verified
Sep 2025
Primary completion
Nov 20, 2030
Completion
Nov 20, 2035

Study Design

Enrollment
15 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (cemiplimab)
    Patients receive cemiplimab IV over 30 minutes on day 1 of each cycle. Cycles repeat every 21 days for up to 32 cycles in the absence of disease progression or unacceptable toxicity. Patients also undergo CT, MRI, and/or digital photography as well as blood sample collection and optional tumor biopsies throughout the study.

Primary Outcome Measure

Overall survival (OS) [ Time Frame: At the beginning of cycle 1, day 1 (each cycle is 21 days) to the time of death from any cause, assessed at 6 months. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Northwestern UniversityChicagoIllinois60611
Jochen H. Lorch
[email protected]
312-694-6959
Jochen H. Lorch (PRINCIPAL_INVESTIGATOR)

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By research site
Northwestern University· Chicago, IL

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