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Metastatic Colorectal CancerPhase 2COMUNITYNCT06557278

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

A Phase 2 study testing AlloStim and Bavencio in people with Metastatic Colorectal Cancer, run by Mirror Biologics, Inc. at 3 sites in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Metastatic Colorectal Cancer
What is being tested?
AlloStim and Bavencio
How many people
0 participants
Where
3 sitesUnited States
Study dates
Nov 2026to Nov 2028
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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)
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  • 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
  • Platelet count ≥ 100,000/mm3
  • Hemoglobin ≥ 9.0 g/dL (may be corrected by transfusion)
  • Adequate Organ Function:
  • Creatinine ≤ 1.5 mg/dL
  • Total bilirubin ≤ 1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤ 2.5 times ULN *
  • Aspartate aminotransferase (AST) or (SGOT) ≤ 2.5 times ULN *
  • Alanine aminotransferase (ALT) or (SGPT) ≤ 2.5 times ULN*
  • EKG without clinically relevant abnormalities
  • Female subjects: Not pregnant or lactating
  • Patients with childbearing potential must have a negative ß-HCG test and agree to use a highly effective contraceptive method during the course of the study
  • Study specific Informed Consent in the native language of the subject
  • ≤ 5 times ULN if liver involvement

Who cannot join

  • 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
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  • 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
  • Progressive viral or bacterial infection
  • o All infections must be resolved and the subject must remain afebrile for seven days without antibiotics prior to being placed on study
  • Cardiac disease of symptomatic nature
  • History of HIV positivity or AIDS
  • History of severe hypersensitivity to monoclonal antibody drugs
  • Psychiatric or addictive disorders or other condition that, in the opinion of the Investigator, would preclude study participation.
  • Subjects that lack ability to provide consent for themselves
  • Any prior cancer diagnosis (other than cured basal cell carcinoma, head and neck carcinoma in-situ, superficial Ta, Tis, T1 bladder cancer, or papillary carcinoma of thyroid) or concurrent cancer histologically different than colorectal adenocarcinoma

Trial locations and contacts

3 sites in 1 country.

United States3 sites

  • Hirschfield Oncology Center

    Brooklyn, New York, 11206

  • Mt. Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • New York Cancer and Blood Specialists

    Shirley, New York, 11967

Other trials in United States

About this study

Official title: Phase II Open-Label Study to Assess the Safety and Efficacy of AlloStim® + Anti-PDL1 as Fourth Line Therapy in 4L MSS Metastatic Colorectal Cancer

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.

Read the detailed description

The protocol provides fourth-line experimental treatment for subjects with microsatellite stable (MSS)/ proficient mismatch repair (pMMR) metastatic colorectal cancer. These patients do not respond to checkpoint inhibitors. This study will investigate whether AlloStim® administered weekly in two-21 day cycles with each cycle consisting of 3 weekly intradermal (ID) doses followed the last week with an intravenous (IV) dose (3 cycles =Days 0 through 49) can prime patients to become responsive to checkpoint inhibition immunotherapy. A restaging computed tomography (CT) scan is conducted on day 56 after the priming and will be compared to the baseline CT scan by Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Scans at day 56 are expected to be read as radiological progression upon restaging after AlloStim® priming, possibly due to immunological swelling, known as "pseudoprogression", consistent with the presumed inflammatory mechanism of action of AlloStim®. This mechanism may convert "cold" tumors to "hot" tumors. The immune cell infiltrates of tumors after AlloStim® include T-helper cell type 1 (Th1) memory cells which produce interferon-gamma. Interferon-gamma is known to increase expression of anti-programmed death ligand 1 (PD-L1) checkpoint molecules in the tumor microenvironment. Higher PD-L1 expression may convert checkpoint inhibitor unresponsive tumors to become checkpoint inhibitor responsive. After two 21-day cycles of AlloStim® priming, a combination of AlloStim® IV boosters and anti-PD-L1 checkpoint therapy (with avelumab 800 mg q/2 weeks) is scheduled between days 63 to day 98, A restaging CT scan at day 112 is then compared to day 56 and baseline to determine if the tumor target lesions\&#39; size has changed. An expansion phase providing another cycle of combined AlloStim® and avelumab is provided for stable patients from days 119-154. A final restaging CT scan is conducted on Day 168 for all subjects.

Being tested
AlloStim, Bavencio
Keywords
colorectal cancer, checkpoint inhibitor, AlloStim, immunotherapy, avelumab
Medical subject headings
Colorectal Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AlloStimBiological

    experimental immunotherapy to prime for checkpoint inhibitor

  • BavencioDrug

    Also called Avelumab

    anti-PDL1 checkpoint inhibitor

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Tumor Response

    CT scan RESIST 1.1

    Measured: day 168

  2. Overall Survival

    survival from signing consent until death by any cause

    Measured: 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2024
  2. Study startNov 2026 (estimated)
  3. Primary completionJun 2028 (estimated)
  4. Study completionNov 2028 (estimated)

Why it stopped: Redesign of protocol for primary end-point of overall survival

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06557278
Sponsor's protocol ID
MBI-006-COMUNITY
Acronym
COMUNITY
Status last verified
Oct 2025
First submitted
8 Aug 2024
Last updated
21 Oct 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AlloStim and Bavencio in people with Metastatic Colorectal Cancer, run by Mirror Biologics, Inc. at 3 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 21 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Tumor Response (time frame: day 168). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06557278.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2025.

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