Practice-entering research
Dostarlimab in dMMR locally advanced rectal cancer (MSK phase II)
A Phase II Study of Induction PD-1 Blockade in Subjects With Locally Advanced Mismatch Repair Deficient Solid Tumors
- Phase
- Phase II
- Recruitment
- Recruiting
- Results maturity
- Primary analysis
- Publication
- Peer-reviewed
- Regulatory approval
- Indication: FDA accelerated approval — 19 Oct 2026 (US; AZUR-1 context). MSK cohort is the pioneering signal.
- NCT
- NCT04165772
- Registry checked
- 2026-10-29
- Editorial update
- 2026-10-29
Not a treatment recommendation. Experimental or ongoing research does not by itself replace standard care.
For patients
What is being studied? In some dMMR rectal cancers, immunotherapy may make the tumor disappear and allow avoiding surgery/radiation/chemotherapy. This does not apply to every patient.
Why promising? PD-1 blockade showed high clinical complete response rates and organ-preservation potential in dMMR locally advanced rectal cancer.
What is not proven? Generalization to all rectal cancers; universal long-term standard; same outcome in pMMR disease.
Is this standard care today? This listing alone does not replace standard care; approval and guideline context require clinician judgment.
For clinicians
NEJM 2022 early cohort 12/12 cCR; NCT04165772. Gold star on Rectum Landmark (`dostarlimab-ilk`, 2026-10-29). AZUR-1 is confirmatory milestone — not a second star. Indication AA: 19 Oct 2026 (US).
Cancer / population: Rectum — Evre II–III dMMR/MSI-H lokal ileri rektum (ve genişletilmiş kohortlar)
Intervention: Dostarlimab (PD-1) indüksiyon; cCR’de non-operatif izlem
Primary endpoint: Sürdürülebilir klinik tam yanıt / yanıt (protokole göre)
Source-verified summary: NEJM 2022: 12/12 cCR (95% CI 74–100). Landmark altın yıldız 2026-10-29. AZUR-1 ayrı doğrulayıcı kilometre taşıdır.
Limitations: Tek merkez erken kohort; uzun dönem ve geniş popülasyon doğrulaması AZUR-1 ile birlikte okunur.
Landmark Atlas links
Cross-links are informational only; this module does not award or change gold stars.