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New treatment option for Sinonasal Melanoma
Official title Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma
ClinicalTrials.gov ID: NCT05546827
What this study is testing
- What it's testing
- 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
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join 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.
You likely can't join 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.
See the full eligibility 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 ≤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...
- 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...
- 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...
- 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.
- Patients must be evaluated by Head and Neck Surgery to establish surgical status as resectable, borderline resectable or unresectable.
- Patients must have a baseline skull base MRI unless contraindicated by medical or financial toxicity. For Arm 2 patients (anorectal melanoma)
- Patients must have histologically or cytologically confirmed melanoma involving the anorectal canal.
- Patients must be evaluated by the surgical team to establish primary tumor surgical status as: (1) resectable with sphincter sparing approach, (2) resectable with abdominoperineal resection, or (3)...
- Patients must have a baseline rectal MRI unless contraindicated by medical or financial toxicity. 2.2
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Houston, Texas, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Houston, Texas, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.