Clinical trialPhase 2Completed
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)
Phase IIA Basket Study of Pixatimod (PG545) in Combination With Nivolumab in PD-1 Relapsed/Refractory Metastatic Melanoma and NSCLC and Pixatimod (PG545) in Combination With Nivolumab and Low-dose Cyclophosphamide in MSS Metastatic Colorectal Carcinoma (mCRC)
- Outcome
- Outcome unknown
- Phase
- Phase 2
- Status
- Completed
- Study type
- Interventional
- Start
- 9 December 2021
- Expected end
- 18 March 2024
- Enrollment
- 13 participants
- Sites
- 1
- Primary outcomes
- Objective Response Rate (ORR); Objective Response Rate (ORR) - Combined Study Population
- Sponsor
- Other
- Results posted
- 2025-03-07
- Last update
- 8 September 2026
These are registry fields. A trial card, with population, design, endpoints and result direction each tied to a quote, is not in the data yet.
Ask this document
Answers come only from this document’s own text, as highlighted quotes. If it doesn’t say, you are told so instead of given a guess.
Try
Source text
Brief summary public domain (ClinicalTrials.gov)
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.
Detailed description public domain (ClinicalTrials.gov)
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. Pixatimod is an investigational drug that activates the toll-like receptor 9 (TLR9) pathway and is being evaluated in studies involving melanoma, non-small cell lung cancer, and microsatellite stable colorectal cancer. 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. This Phase llA trial hypothesizes that the nivolumab/pixatimod combination in PD-1 relapsed/refractory (R/R) cutaneous melanoma and NSCLC patients will be associated with anti-tumor effects, and that the nivolumab/pixatimod/cyclophosphamide combination in MSS mCRC patients will be associated with anti-tumor effect. In the 1st stage, 13 patients will be enrolled in cohort 1 while 9 patients each will be enrolled in cohorts 2 and 3. Should the pre-specified efficacy boundary met, further patients will be enrolled to one or more cohorts in 2nd stage. The total enrollment for 1st stage across all 3 cohorts is 31 response-evaluable patients. The total enrollment for both stages across all 3 cohorts is 61 response-evaluable patients.
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) [Up to 26 months]. Number, percentage of patients. Stable Disease (SD): Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 40; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 37.5. Progressive Disease (PD): Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 60; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 62.5. Analysis, Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 vs Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3: p=1.0000; Fisher Exact; superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Per Immune-related Response Criteria [Up to 26 months]. Number, percentage of patients. Unknown: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 12.5. iStable Disease: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 40.0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 37.5. iUProgressive Disease: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 60.0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 50.0. Analysis, Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 vs Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3: p=1.0000; Fisher Exact; superiority.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Response Per Immune-related Response Criteria - Combined Study Population [Up to 26 months]. Number, percentage of patients. Unknown: Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2 & 3) (n=13): 8. iStable Disease: Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2 & 3) (n=13): 38. iUProgressive Disease: Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2 & 3) (n=13): 54.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Treatment-related Adverse Events [Up to 26 months]. Number, participants. Anemia: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 1; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 0. Lymphocyte count decreased: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 2; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 0. Neutrophil count decreased: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 1; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 0. Alanine aminotransferase increased: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Alkaline phosphatase increased: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Anorexia: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Arthralgia: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Aspartate aminotransferase increased: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Amylase increased: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Fatigue: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 2. Hyperglycemia: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Rash maculo-papular: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1. Weight loss: Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 1.
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
6-month Progression-free Survival (PFS) [Up to 6 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 20 (1 to 58); Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 13 (1 to 42).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
1-year Progression-free Survival (PFS) [Up to 12 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0 (NA to NA) [Upper and lower bound of CI not reached due to low number of events.]; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 13 (1 to 42).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
2-year Progression-free Survival (PFS) [Up to 24 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0 (NA to NA) [Upper and lower bound of CI not reached due to low number of events.]; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 0 (NA to NA) [Upper and lower bound of CI not reached due to low number of events.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) [Up to 27 months]. Median, months (95% Confidence Interval). Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 2.00 (1.00 to NA) [Upper bound of CI not reached due to low number of events.]; Pixatimod (PG545) + Nivolumab - Cohorts 2 & 3 (n=8): 2.00 (1.00 to 5.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) - Combined Study Population [Up to 6 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 15 (2 to 39).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) - Combined Study Population [Up to 12 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 15 (2 to 39).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) - Combined Study Population [Up to 24 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 0 (NA to NA) [Upper and lower bound of CI not reached due to low number of events.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Progression-free Survival (PFS) - Combined Study Population [Up to 27 months]. Median, months (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 2.00 (1.00 to 4.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
6-month Overall Survival (OS) [Up to 6 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 80 (20 to 97); Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 50 (15 to 77).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
1-year Overall Survival (OS) [Up to 12 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0 (NA to NA) [Upper and lower bound of CI not reached due to low number of events.]; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 19 (1 to 54).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
2-year Overall Survival (OS) [Up to 24 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab + Cyclophosphamide - Cohort 1 (n=5): 0 (NA to NA) [Cohort 1, 3 of 5 patients died and 2 of 5 were censored early at the two-year timepoint. No patients remain under follow-up at this time point.]; Pixatimod (PG545) + Nivolumab - Cohort 2 & Cohort 3 (n=8): 0 (NA to NA) [Cohort 2, 6 of 8 patients died and 2 were censored. No patients remain under follow-up at this time point.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) - Combined Study Population [Up to 6 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 62 (31 to 82).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) - Combined Study Population [Up to 12 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 13 (1 to 43).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) - Combined Study Population [Up to 24 months]. Number, percentage of patients (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 0 (NA to NA) [In Cohort 1, 3 of 5 patients died and 2 of 5 patients were censored early at the two-year timepoint. In Cohorts 2/3, 6 of 8 patients died and 2 of 8 patients were censored early at the two-year timepoint. No patients remain under follow-up.].
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Overall Survival (OS) - Combined Study Population [Up to 27 months]. Median, months (95% Confidence Interval). Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2, 3) (n=13): 11.00 (4.00 to 12.00).
Posted results (ClinicalTrials.gov registry) · secondary outcome public domain (ClinicalTrials.gov)
Change in CD8+ T-cells [At baseline, 4 weeks].
Posted results (ClinicalTrials.gov registry) · primary outcome public domain (ClinicalTrials.gov)
Objective Response Rate (ORR) - Combined Study Population [Up to 26 months]. Number, percentage of patients. Stable Disease (SD): Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2 & 3) (n=13): 38. Progressive Disease (PD): Pixatimod (PG545) + Nivolumab or Pixatimod (PG545) + Nivolumab + Cyclophosphamide (Cohorts 1, 2 & 3) (n=13): 62.