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RECTIFY-1: Neoadjuvant Botensilimab + Balstilimab in MSS/pMMR Early Rectal Cancer

ConditionsEarly Rectal CancerStage I Rectal CancerMicrosatellite Stable Rectal Carcinoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorDana-Farber Cancer Institute

About this trial

This is a multi-site, prospective, non-randomized phase 2 study evaluating neoadjuvant botensilimab in combination with balstilimab for patients with microsatellite stable (MSS) / mismatch repair proficient (MMRp) early rectal cancer staged T1-T2 N0 by MRI and considered candidates for surgical resection without standard neoadjuvant therapies. Participants will receive a single IV dose of botensilimab on Day 1 followed by balstilimab IV every 2 weeks for up to 6 months, with tumor response assessments during treatment and follow-up afterward.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed diagnosis of early-rectal cancer clinically staged T1-T2 N0 M0 by MRI (American Joint Committee on Cancer (AJCC) staging 8th edition, 2017).

The tumor must confirmed to be MSS/MMRp by local testing.

The tumor must be evaluable by endoscopy.

Voluntarily agree to participate by giving signed, dated, and written informed consent prior to any study-specific procedures.

Disqualifiers

Tumor is MSI-H/MMRd per any local testing.

Known TMB >20mut/Mb or indication for immune checkpoint inhibitor therapy including hypermutated cancers.

Received prior anti-CTLA-4 or anti-PD-1/PD-L1 therapy and/or other experimental immunologic agents.

Partial or complete bowel obstruction within the last 3 months, signs/symptoms of bowel obstruction, or known radiologic evidence of impending obstruction.

Trial design

Design model

Single group

Treatments tested in this trial

  • Botensilimab

    Drug

    one IV infusion on Cycle 1 Day 1, over about 30 minutes

  • Balstilimab

    Drug

    IV infusion every 2 weeks on Day 1 of each treatment cycle, over about 30 minutes, for up to 6 months

Treatment groups

16 Participants
are divided into 1 treatment group
Group A: Botensilimab + BalstilimabExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Complete response (cCR plus nCR with pCR at resection) within 6 months from initiation of therapy or nCR with pathologic complete response (pCR) with TES

Tumor response will be evaluated by a qualified colorectal surgeon using flexible sigmoidoscopy (or equivalent), with biopsy as clinically indicated, and rectal MRI using standard response criteria. Response categories are clinical complete response, near-complete clinical response, no response, or progression. Participants with near-complete clinical response must have pathologic complete response at TES/local excision to meet the endpoint.

Time frame
From baseline to 6 months from initiation of therapy

Secondary outcomes

1

Incidence of treatment-emergent adverse events

Adverse events will be classified and graded according to NCI CTCAE version 6.0. Toxicity results will be presented descriptively using frequencies and percentages.

Time frame
From first treatment through survival follow-up, up to 5 years from initiation of therapy
2

Incidence of surgical complications

Surgical complications will be graded according to the Clavien-Dindo classification among participants who undergo local excision/TES or total mesorectal excision.

Time frame
From surgery through 90-day safety follow-up
3

Organ preservation rate

Organ preservation rate is defined as the proportion of participants who avoid total mesorectal excision. Local excision/TES without total mesorectal excision is considered organ preservation.

Time frame
From initiation of therapy through post-treatment surgical management decision, approximately 6 months
4

3-year locoregional recurrence rate

Locoregional recurrence rate is defined as the proportion of participants with local or regional recurrence as the initial site of failure within 3 years from initiation of therapy.

Time frame
From initiation of therapy to 3 years.

Other outcomes

Sponsors and contacts

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

Dana-Farber Cancer Institute

Lead sponsor

Agenus Inc.

Collaborator

Gateway for Cancer Research

Collaborator

Source ClinicalTrials.gov
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