Health TrialsbyHealthPanel

Cemiplimab for the Treatment of Incurable Metastatic or Unresectable NUT Carcinoma

ConditionsMetastatic NUT CarcinomaUnresectable NUT Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorNorthwestern University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Patients must have a histologically confirmed NUT carcinoma that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective.

Patient may be treatment naïve or have had prior surgery, radiation, or any systemic therapy (with the exceptions noted in the

Disqualifiers

Patients must have histologically or cytologically confirmed NUT carcinoma based on the ectopic expression of NUT protein per World Health Organization (WHO) criteria as determined by immunohistochemistry (IHC) and/or detection of NUT gene translocation as determined by fluorescence in situ hybridization (FISH) at a Clinical Laboratory Improvement Act (CLIA) certified laboratory and/or by detection of the NUT gene translocation as determined by sequencing (e.g., deoxyribonucleic acid [DNA] next generation sequencing [NGS] or ribonucleic acid [RNA] sequencing) at a CLIA certified laboratory.

Patients must have measurable disease by Response Evaluation Criteria in Solid Tumors (RECIST) v.1.1.

Patients must be age ≥ 18 years.

Patients must exhibit an Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

Trial design

Design model

Single group

Treatments tested in this trial

  • Biopsy Procedure

    Procedure/Surgery

    Undergo optional biopsy

  • Biospecimen Collection

    Procedure/Surgery

    Undergo collection of blood samples

  • Cemiplimab

    Biological/Vaccine

    Given IV

  • Computed Tomography

    Procedure/Surgery

    Undergo CT

  • Digital Photography

    Other intervention

    Undergo digital photography

  • Magnetic Resonance Imaging

    Procedure/Surgery

    Undergo MRI

  • Questionnaire Administration

    Other intervention

    Ancillary studies

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: Treatment (cemiplimab)Experimental treatment 7 interventions

Trial outcomes

Primary outcomes

1

Overall survival (OS)

The statistical analysis plan for the percentage of patients alive at 6 months will primarily involve a survival analysis using Kaplan-Meier methods. The point estimate of the treatment effect, as well as the associated 2-sided 95% confidence interval (CI), will be estimated using a Cox-proportional-hazards model.

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.

Secondary outcomes

1

Overall response rate (ORR)

Will calculate the proportion of treated patients who experience an objective response (confirmed complete response \[CR\] or confirmed partial response \[PR\] per Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1). The date of first response for either CR or PR will be used for the calculation of ORR. The proportion of evaluable patients experiencing an objective response will be estimated with a 95% exact binomial CI. The confidence interval will be adjusted for the sequential nature of the two-stage procedure.

Time frame
Up to 24 months after completion of study treatment
2

Duration of response (DOR)

Response is defined as confirmed CR or confirmed PR per RECIST 1.1; and disease progression is defined as progressive disease per RECIST 1.1. Will be summarized using descriptive statistics, and the CR rate of nuclear protein of testis carcinoma in patients will be determined.

Time frame
From the day of first documented response to trial therapy (CR or PR, whichever is first recorded) and subsequent disease progression, assessed up to 24 months after completion of study treatment
3

Clinical response rate

Will calculate the proportion of treated, evaluable patients who experience clinical benefit from trial therapy. Clinical benefit is defined as confirmed CR; confirmed PR; or stable disease for ≥ 6 months per RECIST 1.1. Will be estimated with a proportion and CI.

Time frame
From the initiation of trial therapy until the patient experiences disease progression, initiates subsequent anti-cancer therapy, or completes study participation (whichever occurs first, assessed up to 24 months after completion of study treatment
4

OS

Will be analyzed using the Kaplan-Meier method. The median OS estimate will be reported along with the CI.

Time frame
From start of treatment (Cycle 1, Day 1) to the time of death from any cause, assessed at up to 24 months after completion of study treatment

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Northwestern University

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
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