RightFit
RecruitingPhase 2

FOLFIRI and Bevacizumab With or Without Pelareorep for Second-Line Treatment of Metastatic RAS-Mutated, Microsatellite-Stable Colorectal Cancer

An Open-Label, Randomized, Multicentre, Phase 2 Study of FOLFIRI + Bevacizumab + Pelareorep vs. FOLFIRI + Bevacizumab for the Second-Line Treatment of Metastatic, RAS-mutated, Microsatellite-Stable (MSS) Colorectal Cancer

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether adding pelareorep to FOLFIRI chemotherapy and bevacizumab works better and is safe. It is for people with colon or rectal cancer that has spread, has a RAS gene change, and is microsatellite-stable (MSS), a tumor test result. Their cancer must have worsened after oxaliplatin treatment, returned soon after it, or they could not tolerate it.

This is an open-label, randomized, multicenter Phase 2 study to assess the efficacy and safety of FOLFIRI + bevacizumab + pelareorep vs. FOLFIRI + bevacizumab in patients with RAS-mutated, MSS mCRC who have progressed after one prior line of oxaliplatin-based therapy.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Have colon or rectal cancer confirmed by a tissue test that has spread and can be measured on scans.
  • Cannot have surgery or radiation to cure the cancer.
  • Cancer worsened during the first oxaliplatin-based treatment for cancer that had spread, or you could not tolerate it; or cancer returned within 6 months after finishing oxaliplatin given after surgery.
  • Are medically able to receive FOLFIRI and bevacizumab.
  • Tumor tests show a known RAS gene change and non-MSI-H or non-dMMR status, results related to how cells repair DNA.
  • Are fully active or can do light work despite limits on hard physical activity.
  • Have good enough blood counts, kidney function, and liver function, and are expected to live at least 6 months.
  • Have a negative pregnancy test if you could become pregnant.

Who can't join

  • Had chemotherapy that treats the whole body, radiation, or surgery less than 4 weeks before study treatment; or still have moderate or worse side effects from cancer treatment.
  • Have received irinotecan before, or have an allergy to a study drug or its drug group.
  • Have cancer that has spread to the brain and causes symptoms.
  • Have an active disease in which the immune system attacks the body, or take medicines that weaken the immune system or lower blood cell production.
  • Have an active infection that is not controlled, known HIV, or active hepatitis B or C needing antiviral treatment.
  • Had another cancer within 3 years, except non-melanoma skin cancer, early-stage prostate cancer, or very early cervical cancer treated to cure it.
  • Have severe or uncontrolled heart disease.
  • Received any vaccine within 28 days before the first study treatment.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Histologically confirmed cancer of the colon or rectum with documented metastasis * Measurable disease per RECIST v. 1.1 * Not candidates for curative surgery or curative radiation * Progressed on, or been intolerant to, a first-line, oxaliplatin-based chemotherapy regimen in the metastatic setting or relapsed within 6 months of completing adjuvant oxaliplatin * Considered medically eligible to receive standard of care (SOC) FOLFIRI with bevacizumab * Non-microsatellite instability high or non-deficient mismatch repair (non-MSI-H/non dMMR) tumor status per a standard local testing method * Tumor confirmed to harbor a known RAS mutation per a standard local testing method * ECOG performance status of 0 or 1 * Patients must have adequate hematological, renal, and hepatic function * Female patients of childbearing potential must have a negative pregnancy test * Life expectancy of at least 6 months Exclusion Criteria: * Undergone systemic chemotherapy, radiotherapy, or surgery, \<4 weeks before study treatment * Ongoing AEs of Grade ≥2 that are related to anti-cancer treatment * Prior treatment with irinotecan * Symptomatic brain metastases * Active autoimmune disease * Receiving immunosuppressive or myelosuppressive medications * Active, uncontrolled infections * Known HIV infection or active hepatitis B or C that requires anti-viral treatment * History of another primary cancer within the last 3 years except for non-melanoma skin cancer, early-stage prostate cancer, or curatively treated cervical carcinoma in-situ * History of allergy or known hypersensitivity to any of the study drugs, study drug classes, * Uncontrolled or severe cardiac disease * Received any vaccine within 28 days prior to first study treatment

Study sites (17)

AL

CA

FL

GA

ID

IL

IN

MI

MO

NJ

OH