Sinonasal MelanomaPhase 2NCT05546827
Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma
A Phase 2 study testing Surgical resection in people with Sinonasal Melanoma and Anorectal Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sinonasal Melanoma, Anorectal Melanoma
- What is being tested?
- Surgical resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Oct 2022to 31 Jul 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
- 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.
- 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) unresectable/requiring surgery greater than abdominoperineal resection.
- Patients must have a baseline rectal MRI unless contraindicated by medical or financial toxicity.
- 2.2 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Devarati Mitra, dmitra@mdanderson.org
Devarati Mitra, MD
About this study
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
Read the 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.
- Conditions
- Sinonasal Melanoma, Anorectal Melanoma
- Being tested
- Surgical resection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Surgical resectionProcedure or surgery
Surgical resection after receiving neodjuvant combination immunotherapy followed by radiation therapy.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Procedure: Surgical resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of Pathologic Response
Measured: through study completion an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Sep 2022
- Study start31 Oct 2022
- Primary completion31 Jul 2028 (estimated)
- Study completion31 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sinonasal MelanomaStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Devarati Mitra, MD, Study chair, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05546827
- Sponsor's protocol ID
- 2022-0330
- Other IDs
- NCI-2022-07760
- Status last verified
- Apr 2026
- First submitted
- 15 Sep 2022
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Preoperative Radiotherapy and Immunotherapy for Sinonasal and Anorectal Mucosal Melanoma
- ClinicalTrials.gov ID
- NCT05546827
- Acronym / sponsor ID
- 2022-0330
- Conditions
- Sinonasal Melanoma, Anorectal Melanoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 31 Oct 2022 (actual)
- Primary completion
- 31 Jul 2028 (estimated)
- Study completion
- 31 Jul 2028 (estimated)
- First posted
- 21 Sep 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sinonasal melanoma: patients with sinonasal melanoma | Experimental | Procedure: Surgical resectionA. 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 |
| Anorectal melanoma: patients with anorectal melanoma | Experimental | Procedure: Surgical resectionA. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (27 listed)
- 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.
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Surgical resectionSurgical resection after receiving neodjuvant combination immunotherapy followed by radiation therapy. | Procedure or surgery | Anorectal melanoma: patients with anorectal melanoma, Sinonasal melanoma: patients with sinonasal melanoma |
Primary outcome
Rate of Pathologic Response
Time frame: through study completion an average of 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- MD Anderson Cancer CenterLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Devarati Mitra, MD study chair
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Surgical resection in people with Sinonasal Melanoma and Anorectal Melanoma, run by M.D. Anderson Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 27 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Devarati Mitra, MD ((713) 563-1339, dmitra@mdanderson.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of Pathologic Response (time frame: through study completion an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.