Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma

NCT05546827 | Recruiting Phase 2 DMC

• 2 other identifiers: 2022-0330NCI-2022-07760
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Sinonasal Melanoma; Anorectal Melanoma

Outcome Measures

Primary Outcomes (1)

• Rate of Pathologic Response

  through study completion an average of 1 year

Study Arms (2)

Sinonasal melanoma: patients with sinonasal melanoma

EXPERIMENTAL

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

Procedure: Surgical resection

Anorectal melanoma: patients with anorectal melanoma

EXPERIMENTAL

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

Procedure: Surgical resection

Interventions

Surgical resection PROCEDURE

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

Anorectal melanoma: patients with anorectal melanoma; Sinonasal melanoma: patients with sinonasal melanoma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• For all patients
• Evidence of mucosal tumor on clinical exam or imaging.
• No evidence of distant metastasis
• Patients must be planned for combination immunotherapy (e.g. ipilimumab and nivolumab or nivolumab and relatlimab).
• ECOG performance status ≤3.
• Age ≥18 years because melanoma is extremely rare in patients \<18 years of age and RT is considered high risk in this population due to risk of secondary malignancy and potentially growing tissues that may be adversely impacted by RT.
• Postmenopausal (no menses in greater than or equal to 12 consecutive months).
• History of hysterectomy or bilateral salpingo-oophorectomy.
• Ovarian failure (Follicle Stimulating Hormone and Estradiol in menopausal range, who have received Whole Pelvic Radiation Therapy).
• History of bilateral tubal ligation or another surgical sterilization procedure. Approved methods of birth control are as follows: Hormonal contraception (i.e. birth control pills, injection, implant, transdermal patch, vaginal ring), Intrauterine device (IUD), Tubal Ligation or hysterectomy, Subject/Partner post vasectomy, Implantable or injectable contraceptives, and condoms plus spermicide. Not engaging in sexual activity for the total duration of the trial and the drug washout period is an acceptable practice; however periodic abstinence, the rhythm method, and the withdrawal method are not acceptable methods of birth control. Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately.
• Men treated or enrolled on this protocol must also agree to use adequate contraception prior to the study, for the duration of study participation, and 6 months after completion of RT.
• Patients with a prior or concurrent malignancy whose natural history or treatment does not have the potential to interfere with their ability to safely receive the study interventions are eligible for this trial.
• Ability to understand and the willingness to sign a written informed consent document.
• For Arm 1 patients (sinonasal melanoma)
• Patients must have histologically or cytologically confirmed melanoma involving the nasal cavity and/or paranasal sinuses.

You may not qualify if:

• Previous radiation therapy to the planned target area (sinonasal for Arm 1 and anorectal for Arm 2).
• Metastatic disease
• Pregnant women are excluded from this study because RT is a known teratogen.
• Patients who are less than 18 years of age because melanoma is extremely rare in this population and the treatment agent is a known carcinogen.

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

RECRUITING

Related Links

• MD Anderson Cancer Center

Study Officials

• Devarati Mitra, MD

  M.D. Anderson Cancer Center

  STUDY CHAIR

Central Study Contacts

Devarati Mitra, MD

CONTACT

(713) 563-1339; dmitra@mdanderson.org

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 15, 2022
• First Posted: September 21, 2022
• Study Start: September 23, 2022
• Primary Completion (Estimated): July 31, 2028
• Study Completion (Estimated): July 31, 2028
• Last Updated: May 4, 2026

Record last verified: 2026-04

Locations

US (1)