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

ConditionsRas-mutated Metastatic Colorectal CancermCRCMSS Metastatic Colorectal Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorOncolytics Biotech

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bevacizumab

    Drug

    Bevacizumab (5 mg/kg) IV infusion

  • FOLFIRI

    Drug

    irinotecan (180mg/m2), leucovorin 400 mg/m2 ± 5-FU (400 mg/m2) IV infusion

  • Pelareorep

    Drug

    pelareorep 4.5 x 10\^10 TCID50 IV infusion

Treatment groups

60 Participants
are divided into 2 treatment groups
Group A: Arm AExperimental treatment 3 interventions
Group B: Arm BExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Overall Response Rate (ORR)

Proportion of patients with complete response \[CR\], partial response \[PR\] assessed by the investigators and/or central reader according to RECIST v1.1

Time frame
At week 8

Secondary outcomes

1

Overall Survival (OS) -

OS defined as the time from date of randomization to death from any cause

Time frame
From the date of randomization through long term follow up at two years
2

Progression Free Survival (PFS)

Time from randomization to the date of investigator-determined objective progression (according to RECIST 1.1) or death from any cause, whichever occurs first.

Time frame
From randomization to objective progression or death from any cause, whichever occurs first, up to two years
3

Disease Control Rate (DCR)

Overall DCR, defined as the number of patients with a best overall response of CR, PR, or SD according to RECIST v. 1.1

Time frame
From randomization to disease progression or death from any cause, whichever occurs first, up to two years
4

Duration of Response (DOR)

Time from documentation of the first CR or PR to the time of first documented evidence of progressive disease (or relapse for subjects who experience CR during the study) or death.

Time frame
From randomization to disease progression or death from any cause, whichever occurs first, up to two years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Oncolytics Biotech

Lead sponsor

Source ClinicalTrials.gov
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