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)

PHASE2CompletedINTERVENTIONAL
Enrollment

13

Participants

Timeline

Start Date

December 9, 2021

Primary Completion Date

February 5, 2024

Study Completion Date

March 18, 2024

Conditions
NSCLCMetastatic Colorectal CarcinomaRefractory Melanoma
Interventions
DRUG

Pixatimod

Pixatimod is an investigational drug that is being evaluated in studies involving melanoma, non-small cell lung cancer, and microsatellite stable colorectal cancer.

DRUG

Nivolumab

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

DRUG

Cyclophosphamide (low dose)

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

Trial Locations (1)

15232

UPMC Hillman Cancer Center, Pittsburgh

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

Aculeus Therapeutics

UNKNOWN

lead

Diwakar Davar

OTHER

NCT05061017 - 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) | Biotech Hunter | Biotech Hunter