Adding pelareorep to FOLFIRI and bevacizumab for second-line RAS‑mutated, MSS metastatic colorectal cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is an open‑label, randomized, multicenter Phase 2 trial that will randomize about 60 patients 1:1 to receive either FOLFIRI plus bevacizumab with pelareorep or FOLFIRI plus bevacizumab alone. The primary endpoint is objective response rate by investigator assessment using RECIST 1.1, with secondary endpoints including overall survival, progression‑free survival, and safety/tolerability. Eligible patients must have histologically confirmed metastatic colorectal cancer with a documented RAS mutation, be microsatellite‑stable (non‑MSI‑H/non‑dMMR), have progressed after an oxaliplatin‑based first line, and have ECOG performance status 0–1. Tumor assessments will be performed after treatment initiation and secondary analyses occur at end of study.

Why it matters

Who can join: the full rules

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

Where it's running

• Central Alabama Research
  Homewood, Alabama, United States Recruiting
• Clinical Research Advisors (Beverly Hills)
  Beverly Hills, California, United States Recruiting
• Clinical Research Advisors (Encino)
  Encino, California, United States Recruiting
• Clinical Research Advisors (Korea Town)
  Koreatown, California, United States Recruiting
• Clinical Research Advisors (Downtown LA)
  Los Angeles, California, United States Recruiting
• Clinical Research Advisors (West Hollywood)
  Los Angeles, California, United States Recruiting

Study contacts

• Study coordinator: Name: Reference Study ID Number: REO 033
• Email: REO-033@oncolytics.com
• Phone: +1 (858) 247-7829

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Torvutatug samrotecan plus bevacizumab as first-line maintenance in non-HRD advanced epithelial ovarian cancer

  This trial tests whether adding torvu-samrotecan to bevacizumab after standard chemotherapy helps people with non-HRD advanced epithelial ovarian cancer live longer without the cancer worsening compared with bevacizumab alone.

  Recruiting at 4 sites Phase 3 AstraZeneca · Tamarac, Florida and 219 other locations · NCT07851025

• HAIC plus QL1706 and bevacizumab as first-line therapy for unresectable HER2-negative intrahepatic cholangiocarcinoma

  This study tests a liver-directed chemotherapy plus immune therapy and a blood vessel blocker to see if it helps people with unresectable intrahepatic cholangiocarcinoma.

  Recruiting Phase 2 Sun Yat-sen University · Guangzhou, Guangdong · NCT07841574

• Bevacizumab for severe HHT-related nosebleeds

  This study tests whether bevacizumab can help people with hereditary hemorrhagic telangiectasia who have severe nosebleeds.

  Recruiting Phase 2 Second Affiliated Hospital, Zhejiang University, School of Medicine · Hangzhou, Zhejiang · NCT07828015

• Torvutatug samrotecan with or without bevacizumab as maintenance in platinum-sensitive relapsed epithelial ovarian, fallopian tube, or primary peritoneal cancer

  This study tests torvutatug samrotecan, with or without bevacizumab, to see if it helps people with platinum-sensitive relapsed ovarian, fallopian tube, or primary peritoneal cancer stay cancer-free longer after their last platinum therapy.

  Recruiting at 3 sites Phase 3 AstraZeneca · Anchorage, Alaska and 123 other locations · NCT07816666

• Trastuzumab plus bevacizumab vs bevacizumab alone as first-line maintenance therapy for ovarian cancer

  This trial tests whether adding trastuzumab to bevacizumab maintenance helps people with epithelial ovarian cancer after initial platinum-based therapy.

  Recruiting at 3 sites Phase 3 Suzhou Suncadia Biopharmaceuticals Co., Ltd. · Beijing, Beijing Municipality and 2 other locations · NCT07779538

• Raludotatug Deruxtecan With or Without Bevacizumab as First‑Line Maintenance in Advanced Ovarian Cancer

  This trial tests whether maintenance therapy with raludotatug deruxtecan, with or without bevacizumab, helps people with advanced ovarian, fallopian tube, or primary peritoneal cancer live longer without the cancer growing after initial treatment.

  Recruiting at 13 sites Phase 3 Merck Sharp & Dohme LLC · Washington D.C., District of Columbia and 12 other locations · NCT07776691

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.