Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

Conditions

• Anorectal Melanoma
• Sinonasal Melanoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Surgical resection — PROCEDURE
  Surgical resection after receiving neodjuvant combination immunotherapy followed by radiation therapy.

Study Details

The goal of this clinical research study is to learn if pre-operative radiation therapy after starting immune checkpoint inhibition can help patients with sinonasal or anorectal melanoma have better outcomes

Key Dates

Start date

Sep 23, 2022

Status verified

Apr 2026

Primary completion

Jul 31, 2028

Completion

Jul 31, 2028

Study Design

Enrollment

40 participants (estimated)

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Sinonasal melanoma: patients with sinonasal melanoma
  A. Patients with upfront resectable disease Treatment: * Immunotherapy * 20 fraction radiation therapy +/- ongoing immunotherapy * Surgery B. Patients whose disease is not resectable at presentation Treatment: Immunotherapy with potential to enter resectable disease pathway if tumor becomes resectable or continue treatment as per multidisciplinary team preference if tumor does not become resectable
• Experimental: Anorectal melanoma: patients with anorectal melanoma
  A. Patients with disease resectable with a sphincter sparing procedure Treatment: * Immunotherapy * 5 fraction radiation therapy * Surgery B. Patients with disease not resectable with a sphincter sparing procedure Treatment: * Immunotherapy to maximal response * 5 or 15 fraction radiation (depending on immunotherapy response) +/- ongoing immunotherapy * Surgery or biopsy

Primary Outcome Measure

Rate of Pathologic Response [ Time Frame: through study completion an average of 1 year ]

Central Contacts

• Devarati Mitra, MD
  (713) 563-1339
  [email protected]

Locations (1)

Find similar trials in Houston, TX