Stereotactic Body Radiotherapy for Melanoma

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Melanoma+5 MoreStereotactic Body Radiotherapy - Radiation
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a combination of two different types of cancer treatment: checkpoint inhibitors and stereotactic body radiation therapy (SBRT). Checkpoint inhibitors help the immune system fight cancer, while SBRT is a type of radiation therapy that gives high doses of radiation to tumors with high precision. The use of checkpoint inhibitors in combination with SBRT has been suggested to improve the immune response against cancer, but this combination has not been tested in a formal clinical trial before. Up to three lesions can be treated with SBRT in this study.

Eligible Conditions
  • Melanoma
  • Metastatic Cancer
  • Head and Neck Cancers
  • Kidney Cancer
  • Bladder Cancer
  • Lung Cancer

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 0 Secondary · Reporting Duration: 24 weeks

24 weeks
evaluate overall response rate (ORR)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Side Effects for

SBRT With Gem
15%ulcer
10%vomiting
5%Perforation
5%pain
This histogram enumerates side effects from a completed 2008 Phase 2 trial (NCT00350142) in the SBRT With Gem ARM group. Side effects include: ulcer with 15%, vomiting with 10%, Perforation with 5%, pain with 5%.

Trial Design

1 Treatment Group

Stereotactic Body Radiotherapy
1 of 1

Experimental Treatment

60 Total Participants · 1 Treatment Group

Primary Treatment: Stereotactic Body Radiotherapy · No Placebo Group · Phase 2

Stereotactic Body RadiotherapyExperimental Group · 2 Interventions: Stereotactic Body Radiotherapy, Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab · Intervention Types: Radiation, Biological
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stereotactic Body Radiotherapy
2008
Completed Phase 2
~220

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 24 weeks

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor
1,832 Previous Clinical Trials
584,478 Total Patients Enrolled
74 Trials studying Melanoma
15,872 Patients Enrolled for Melanoma
Yoshiya Yamada, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center
7 Previous Clinical Trials
88 Total Patients Enrolled

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
Subjects must be willing to comply with the study's requirements, which include scheduled visits, treatment, laboratory testing, and other obligations.
Any type of cancer that has spread to other parts of the body and that is known to respond to treatments that block certain proteins called "immune checkpoints" can be treated with these drugs, according to the FDA
The treating radiation oncologist must believe that one lesion is safe to irradiate
The patient has been treated with an immune checkpoint inhibitor for at least two months
People who participate in experiments must agree to what is happening and sign a document stating this
People over the age of 18 who are male or female.
The patient has a good performance status, with a score of 2 or lower on the Eastern Cooperative Oncology Group scale.
The patient has evidence of a limited progression of their illness, as determined by their doctor, with up to five lesions
The patient must be eligible to continue to receive an immune checkpoint inhibitor after radiotherapy is complete.
At least one lesion that meets the criteria for radiation therapy, as measured by CT or MRI.