Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma

Part of paid clinical trials in Orange, California.

Sponsor
University of California, Irvine
Study ID
NCT06771544
Phase
PHASE2
Status
Recruiting
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Conditions

  • Melanoma
  • Melanoma (Skin)
  • Melanoma Stage III
  • Melanoma Stage IV

Eligibility Criteria

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

Interventions

  • Pembrolizumab — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given PO

Study Details

This is a phase 2, single-arm, open label clinical trial determining efficacy of Cyclophosphamide and Pembrolizumab in subjects with melanoma.

Key Dates

Start date
Dec 23, 2024
Status verified
Mar 2026
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: Pembrolizumab + Cyclophosphamide
    Pembrolizumab 200mg IV every 21 days or 400 mg IV every 42 days Cyclophosphamide 50mg PO daily on days 1-14 every 21 days for melanoma patients

Primary Outcome Measure

Objective Response Rate (ORR) by RECIST v1.1 [ Time Frame: Up to 3 years ]

Central Contacts

  • Chao Family Comprehensive Cancer Center University of California, Irvine
    1-877-827-8839
    [email protected]
  • University of California Irvine Medical

Locations (1)

FacilityCityStateZIPSite coordinators
Chao Family Comprehensive Cancer Center University of California, IrvineOrangeCalifornia92868
Warren Chow, MD
[email protected]
877-827-8839

Find similar trials in Orange, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
Chao Family Comprehensive Cancer Center University of California, Irvine· Orange, CA

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