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NCT06843434 · ClinicalTrials.gov registry record · Phase 2
A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma
A Phase 2 study of Locally Advanced Rectal Adenocarcinoma and Microsatellite Stable Rectal Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
- Recruiting
- Registry status
- Phase 2
- Development phase
- 40
- Enrollment target
- 7
- Study locations
NCT06843434: Recruiting Phase 2 study of Locally Advanced Rectal Adenocarcinoma and Microsatellite Stable Rectal Carcinoma, sponsored by Memorial Sloan Kettering Cancer Center.
NCT06843434 is a Phase 2 study of Locally Advanced Rectal Adenocarcinoma and Microsatellite Stable Rectal Carcinoma that is actively recruiting participants, run by Memorial Sloan Kettering Cancer Center. The registered enrollment target is 40 participants, below the 101-participant average among 5 other Locally Advanced Rectal Adenocarcinoma trials with a reported enrollment target (60% lower). The trial reports 7 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06843434, a Phase 2 study of Locally Advanced Rectal Adenocarcinoma and Microsatellite Stable Rectal Carcinoma, is actively recruiting participants, sponsored by Memorial Sloan Kettering Cancer Center.
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 40 participants
- Enrollment target
- 7
- Study locations
Study Summary
The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The investigators will also find out whether BOT/BAL is an effective treatment when given in combination with standard chemotherapy.
Primary Outcome
The primary objective of this study is to determine the best overall response rate (ORR) after initial neoadjuvant combination botensilimab and balstilimab in subjects with MMRp/MSS locally advanced (stage II or III) rectal adenocarcinoma. ORR is defined by rectal MRI and endoscopic exam and graded as progressive disease (PD), stable disease (SD) (sustained for 3 months), partial response (PR), near complete response (nCR) and clinical complete response (cCR). Patients with PR, nCR, or cCR will
Conditions Studied
Interventions
- DRUG Balstilimab
- DRUG Botensilimab
Study Locations (7)
New York
- Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities) - Commack
- Memorial Sloan Kettering Westchester (Limited Protocol Activities) - Harrison
- Memorial Sloan Kettering Cancer Center (All Protocol Activities) - New York
- Memorial Sloan Kettering Nassau (Limited Protocol Activities) - Uniondale
New Jersey
- Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities) - Basking Ridge
- Memorial Sloan Kettering Monmouth (Limited Protocol Activities) - Middletown
- Memorial Sloan Kettering Bergen (Limited Protocol Activities) - Montvale
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 40 participants |
| Start Date | 2025-02-20 |
| Est. Completion | 2028-02-20 |
| Phase | Phase 2 |
What NCT06843434 shows while recruiting
NCT06843434 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 101-participant average among 5 other Locally Advanced Rectal Adenocarcinoma trials with a reported enrollment target (60% lower).
The record links to 2 conditions, with Locally Advanced Rectal Adenocarcinoma appearing as the primary indexed condition, and to 2 interventions - of which Balstilimab is the first listed.
NCT06843434 lists 7 locations in 2 states (New York, New Jersey).
Frequently Asked Questions
What is clinical trial NCT06843434 about?
NCT06843434 is a clinical study titled "A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma". The purpose of this study is to find out whether the combination of botensilimab and balstilimab (BOT/BAL) is a safe and effective treatment that causes few or mild side effects for people with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced rectal adenocarcinoma. The ...
What is the current status of trial NCT06843434?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 40 participants. The study started on 2025-02-20. Estimated completion is 2028-02-20.
What conditions does trial NCT06843434 study?
This clinical trial studies the following conditions: Locally Advanced Rectal Adenocarcinoma, Microsatellite Stable Rectal Carcinoma.
What interventions are being tested in trial NCT06843434?
The interventions under investigation include: Balstilimab (DRUG), Botensilimab (DRUG).
Who is sponsoring clinical trial NCT06843434?
This trial is sponsored by Memorial Sloan Kettering Cancer Center, which has 1,884 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06843434 being conducted?
This trial has 7 study locations across New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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