Recruiting
Phase 2

Nodal Radiation Therapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT04594187

Conditions

Melanoma

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Immunotherapy

Quality-of-Life Assessment

Radiation Therapy

Study Details

Brief summary:

This phase II trial seeks to determine the role of nodal radiation therapy after sentinel lymph node biopsy (SLNB) for patients with high risk sentinel lymph node positive melanoma who are planned for immunotherapy without completion lymph node dissection. Prior studies of patients with more advanced melanoma have shown nodal radiation therapy can decrease the risk of nodal recurrence but it is not known if this same benefit will be seen in patients with high risk sentinel lymph node positive disease who are planned for immunotherapy.

Conditions

Melanoma

Study ID

NCT04594187

Start date

Aug 7, 2020

Status verified date

Aug, 2026

Completion date

Dec 31, 2027

Anticipated

Primary completion date

Dec 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Must be planned for post-operative immunotherapy
  • No evidence of distant metastasis as determined by clinical examination and any form of imaging
  • No evidence of clinically involved lymph nodes prior to SLNB
  • Pathologically confirmed sentinel lymph node positive melanoma with high risk features (extracapsular extension \[ECE\] or 0.5 mm+ nodal tumor implant or 2+ involved nodes or lymphovascular invasion of the primary tumor)
  • Has provided written informed consent for participation in this trial
  • Eastern Cooperative Oncology Group (ECOG) performance status of 3 or less
  • Life expectancy greater than 6 months
  • Patients capable of childbearing are using adequate contraception
  • Available for follow-up

Exclusion Criteria:

  • Complete lymph node dissection (CLND) of the nodal basin containing the positive SLN
  • Distant metastasis
  • Previous radiation therapy (RT) to the nodal area planned for RT such that the prior RT field would be included in the current treatment field. In other words, treatment on this trial would require re-irradiation of tissues
  • Women who are pregnant
  • Adults unable to consent, individuals who are not yet adults, pregnant women and prisoners will be excluded from this study

Study Design

Enrollment

168 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Group I (immunotherapy, radiation therapy)

Within 12 weeks of SLNB, patients start nodal radiation therapy (30 Gy in 5 treatments over 2-2.5 weeks). Immunotherapy planned to begin at any time after SLNB.

active comparator: Group II (immunotherapy)

Patients planned to undergo immunotherapy.

Interventions

Immunotherapy

All patients must be planned for treatment with any immunotherapy agent after sentinel lymph node biopsy (e.g. pembrolizumab or nivolumab). For patients receiving radiation therapy initiation may be before, during or after radiation.

Quality-of-Life Assessment

Ancillary studies

Radiation Therapy

Undergo nodal radiation therapy

Primary outcome measure

  • Time to regional nodal recurrence [ Time Frame: From date of sentinel lymph node biopsy, assessed up to 5 years ]

Central Contacts and Locations

Central contacts

Devarati Mitra

713-563-1339dmitra@mdanderson.org

Locations

Baptist - MD Anderson Cancer Center

Recruiting

Jacksonville, Florida, United States, 32207

Contacts

Cynthia Anderson, MD

904-202-7300cynthia.anderson@bmcjax.com

Cooper Hospital UNIV MED CTR.

Recruiting

Camden, New Jersey, United States, 08103

Contacts

Gregory Kubicek, MD

855-632-2667Kubicek-Gregory@CooperHealth.edu

Principal Investigator:

Gregory Kubicek, MD

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Devarati Mitra

713-563-1339dmitra@mdanderson.org

Principal Investigator:

Devarati Mitra

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.