Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma
Overview
- Phase
- Phase 2
- Intervention
- Surgical resection
- Conditions
- Not specified
- Sponsor
- M.D. Anderson Cancer Center
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Rate of Pathologic Response
- Status
- Recruiting
- Last Updated
- 2 months ago
Overview
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
Detailed Description
To determine the rate of pathologic response (\<50% viable tumor or \>50% fibrosis) for non-metastatic sinonasal melanoma patients having surgical resection after receiving neoadjuvant combination immunotherapy followed by radiation therapy. To determine the rate of pathologic response (\<50% viable tumor or \>50% fibrosis) for non-metastatic anorectal melanoma patients receiving neoadjuvant intent combination immunotherapy followed by radiation therapy.
Investigators
Eligibility Criteria
Inclusion Criteria
- •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 ≤
- •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.
- •RT is a known teratogen. For this reason women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. (refer to MDA Policy CLN 1114) This includes all female patients, between the onset of menses and 55 years unless the patient presents with an applicable exclusionary factor which may be one of the following:
- •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).
Exclusion Criteria
- •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.
Arms & Interventions
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
Intervention: Surgical resection
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
Intervention: Surgical resection
Outcomes
Primary Outcomes
Rate of Pathologic Response
Time Frame: through study completion an average of 1 year