Pembrolizumab for Advanced Cutaneous Sarcomas Not Including Angiosarcoma

Conditions

• Cutaneous Sarcoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Outpatient infusion

Study Details

This is a single arm, open-label phase II study to assess the efficacy of single agent pembrolizumab for the treatment of advanced cutaneous sarcomas. Adult patients ≥18 years old who have been diagnosed with an advanced cutaneous sarcoma without regard to race, ethnicity, and/or gender. Approximately N=17 patients are planned to be enrolled. Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks).

Key Dates

Start date

Jun 20, 2025

Status verified

Mar 2026

Primary completion

Jul 31, 2030

Completion

Jul 31, 2030

Study Design

Enrollment

17 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab Treatment
  Pembrolizumab 200 mg will be administered as 30-minute IV infusion every 21 days (3 weeks).

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 3 years ]

Central Contacts

• Kristie Newsome
  813-745-5978
  [email protected]

Locations (3)

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