A Study of Botensilimab and Balstilimab for Rectal Adenocarcinoma

Part of paid clinical trials in Basking Ridge, New Jersey.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT06843434
Phase
PHASE2
Status
Recruiting
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Conditions

  • Locally Advanced Rectal Adenocarcinoma
  • Microsatellite Stable Rectal Carcinoma

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Balstilimab — DRUG
    Balstilimab is a fully human monoclonal IgG4 antibody designed to block PD-1 binding to PD-L1 and PD-L2
  • Botensilimab — DRUG
    Botensilimab is a novel fully human fragment crystallizable (Fc)-engineered immunoglobulin 1 kappa (IgG1κ) anti-CTLA-4 immunoglobulin G1 (IgG1) antagonist antibody that is designed to optimally promote fragment-crystallizable gamma receptor (FcγR) effector functions that are important for enhancing T cell priming and regulatory T cell (Treg) depletion.

Study Details

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.

Key Dates

Start date
Feb 20, 2025
Status verified
Apr 2026
Primary completion
Feb 20, 2028
Completion
Feb 20, 2028

Study Design

Enrollment
40 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Participants with locally advanced rectal cancer
    Up to 40 patients with mismatch repair proficient (MMRp)/microsatellite stable (MSS) locally advanced (stage II or III) rectal cancer

Primary Outcome Measure

Best Overall Response Rate [ Time Frame: 1 year ]

Central Contacts

Locations (7)

FacilityCityStateZIPSite coordinators
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)Basking RidgeNew Jersey07920
Andrea Cercek, MD
646-888-4189
Andrea Cercek, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Monmouth (Limited Protocol Activities)MiddletownNew Jersey07748
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Bergen (Limited Protocol Activities)MontvaleNew Jersey07645
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)CommackNew York11725
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Westchester (Limited Protocol Activities)HarrisonNew York10604
Andrea Cercek, MD
646-888-4189
Memorial Sloan Kettering Cancer Center (All Protocol Activities)New YorkNew York10065
Andrea Cercek, MD
646-888-4189
Andrea Cercek, MD (PRINCIPAL_INVESTIGATOR)
Memorial Sloan Kettering Nassau (Limited Protocol Activities)UniondaleNew York11553
Andrea Cercek, MD
646-888-4189

Find similar trials in Basking Ridge, NJ

By research site
Memorial Sloan Kettering Basking Ridge (Limited Protocol Activities)· Basking Ridge, NJMemorial Sloan Kettering Monmouth (Limited Protocol Activities)· Middletown, NJMemorial Sloan Kettering Bergen (Limited Protocol Activities)· Montvale, NJMemorial Sloan Kettering Cancer Center at Suffolk - Commack (Limited Protocol Activities)· Commack, NYMemorial Sloan Kettering Westchester (Limited Protocol Activities)· Harrison, NYMemorial Sloan Kettering Cancer Center (All Protocol Activities)· New York, NY

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