Pixatimod (PG545) Plus Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and With Nivolumab and Low-dose Cyclophosphamide in MSS Metastatic Colorectal Carcinoma (mCRC)

Part of paid clinical trials in Pittsburgh, Pennsylvania.

Sponsor
Diwakar Davar
Study ID
NCT05061017
Phase
PHASE2
Status
Completed

Conditions

  • Metastatic Colorectal Carcinoma
  • NSCLC
  • Refractory Melanoma

Eligibility Criteria

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

Interventions

  • Pixatimod — DRUG
    Pixatimod is an investigational drug that is being evaluated in studies involving melanoma, non-small cell lung cancer, and microsatellite stable colorectal cancer.
  • Nivolumab — DRUG
    Nivolumab is approved by the FDA for the treatment of melanoma, non-small cell lung cancer (NSCLC), malignant pleural mesothelioma, renal cell carcinoma, classical Hodgkin lymphoma, squamous cell carcinoma of head/neck, urothelial carcinoma, MSI-H colorectal cancer, hepatocellular carcinoma, gastric carcinoma and gastroesophageal junction (GEJ) cancer
  • Cyclophosphamide (low dose) — DRUG
    Cyclophosphamide is approved by the FDA for the treatment of acute lymphoblastic leukemia, acute monocytic leukemia, acute myeloid leukemia, breast cancer, chronic granulocytic leukemia, chronic lymphocytic leukemia, chronic myelogenous leukemia, Hodgkin lymphoma, multiple myeloma, mycosis fungoides, neuroblastoma, non-Hodgkin lymphoma, ovarian cancer, retinoblastoma. Low-dose (immunomodulatory) cyclophosphamide is being studied in combination with various types of immunotherapy including nivolumab and pembrolizumab

Study Details

The primary goal of this trial is to assess clinical response to nivolumab and pixatimod, and, nivolumab, pixatimod and cyclophosphamide in three separate patient cohorts. Cohort 1: MSS mCRC in combination with low-dose cyclophosphamide, Cohort 2: PD-1 relapsed/refractory melanoma, and Cohort 3: PD-1 relapsed/refractory NSCLC.

Key Dates

Start date
Dec 9, 2021
Status verified
Mar 2025
Primary completion
Feb 5, 2024
Completion
Mar 18, 2024

Study Design

Enrollment
13 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Pixatimod (PG545) + Nivolumab
    Pixatimod : 25 mg IV, weekly Nivolumab: 480 mg IV, Q4 weeks Cohort 1 (MSS CRC)
  • Experimental: Pixatimod (PG545) + Nivolumab + cyclophosphamide
    Pixatimod : 25 mg IV, weekly Nivolumab: 480 mg IV, Q4 weeks cyclophosphamide: 50 mg PO twice daily (Day 1-Day 7; Day 15-Day 21) with a 7-day drug free interval (Day 8-Day 14 and Day 22-Day 28) Cohort 2 (PD-1 R/R melanoma) and Cohort 3 (PD-1 R/R NSCLC)

Primary Outcome Measure

Objective Response Rate (ORR) [ Time Frame: Up to 26 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-

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