Combined AlloStim+Anti-PD-L1 in 4L MSS Metastatic Colorectal Cancer

NCT06557278 | Withdrawn Phase 2 DMC FDA Drug

• 1 other identifier: MBI-006-COMUNITY
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 3

Brief Summary

Experimental immunotherapy in chemotherapy-refractory and immunotherapy-refractory metastatic colorectal cancer patients that have progressed, or are intolerant to, Longsurf (TAS-102) +/- Avastin (bevacizumab) or Stivarga (regorafenib) or Fruzaqla (fruquintinib) combining experimental AlloStim with an anti-programmed death ligand 1 (PD-L1) checkpoint inhibitor drug.

Conditions

Metastatic Colorectal Cancer

Keywords

colorectal cancer; checkpoint inhibitor; AlloStim; immunotherapy; avelumab

Outcome Measures

Primary Outcomes (2)

• Objective Tumor Response

  CT scan RESIST 1.1

  day 168

• Overall Survival

  survival from signing consent until death by any cause

  2 years

Interventions

AlloStim BIOLOGICAL

experimental immunotherapy to prime for checkpoint inhibitor

Bavencio DRUG

anti-PDL1 checkpoint inhibitor

Also known as: Avelumab

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult male and female subjects aged 18-80 years at screening visit
• Pathologically confirmed diagnosis of MSS/pMMR colorectal adenocarcinoma
• Presenting with metastatic disease:
• Primary tumor can be intact or previously resected
• Previous treatment failure of at least two lines of active systemic chemotherapy:
• Previous chemotherapy must have included a fluoropyrimidine, oxaliplatin (e.g. FOLFOX, CAPOX), and irinotecan-containing (e.g. FOLFIRI) regimens (single regimen of FOLFIRINOX satisfies)
• Administered in adjuvant setting or for treatment of metastatic disease
• If KRAS wild type, must have at least one prior anti-EGFR therapy if left sided primary tumor
• Treatment failure or refusal/not qualified for at least one third-line treatment
• TAS-102 +/- bevacizumab or regorafenib or fruquinib
• Treatment failure can be due to disease progression or toxicity
• Time from last treatment failure to Informed Consent must be no more than 30 days
• ECOG performance score: 0-1
• Adequate hematological function:
• Absolute granulocyte count ≥ 1,200/mm3

You may not qualify if:

• High frequency microsatellite instability (MSI-H) or deficient mismatched repair dMMR
• Bowel obstruction or high risk for obstruction if tumors become inflamed
• Moderate or severe ascites requiring medical intervention
• Clinical evidence of brain metastasis or leptomeningeal involvement
• Widespread peritoneal carcinomatous (e.g. CT scan shows innumerable lesions visible and/or abnormal thickening of greater omentum) that increases risk of a major morbidity (e.g. bowel obstruction) in the opinion of the Investigator
• COPD
• Pulmonary lymphangitis or symptomatic pleural effusion (grade ≥ 2) that results in pulmonary dysfunction requiring active treatment; or, oxygen saturation \<92% on room air
• Any of the following mood disorders: active major depressive episode, recent history of suicidal attempt or ideation
• Prior allogeneic bone marrow/stem cell or solid organ transplant
• Chronic use (\> 2 weeks) of greater than physiologic doses of a corticosteroid agent (dose equivalent to \> 5 mg/day of prednisone) planned or anticipated during the study before the end of the Safety Evaluation Period (28 days after the last dose of IP)
• Topical corticosteroids are permitted
• Prior diagnosis of an active autoimmune disease (e.g., rheumatoid arthritis, multiple sclerosis, autoimmune thyroid disease, uveitis)
• Well controlled Type I diabetes allowed (HbA1c \< 8.5%)
• Prior experimental immunotherapy
• History of blood transfusion reactions

Sponsors & Collaborators

• Mirror Biologics, Inc.: lead

Study Sites (3)

Mt. Sinai Comprehensive Cancer Center

Miami Beach, Florida, 33140, United States

Location

Hirschfield Oncology Center

Brooklyn, New York, 11206, United States

Location

New York Cancer and Blood Specialists

Shirley, New York, 11967, United States

Location

Related Links

• Case Report

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

avelumab

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2024
• First Posted: August 16, 2024
• Study Start (Estimated): November 1, 2026
• Primary Completion (Estimated): June 1, 2028
• Study Completion (Estimated): November 1, 2028
• Last Updated: October 21, 2025

Record last verified: 2025-10

Locations

US (3)