A Study of Several Radiation Doses for Patients With Progression on Immunotherapy/Checkpoint Inhibitors

Part of paid clinical trials in Hartford, Connecticut.

Sponsor
Memorial Sloan Kettering Cancer Center
Study ID
NCT03693014
Phase
PHASE2
Status
Active Not Recruiting

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Stereotactic Body Radiotherapy — RADIATION
    (27 Gy over 3 fractions)
  • Ipilimumab, Nivolumab, Pembrolizumab or Atezolizumab — BIOLOGICAL
    The checkpoint inhibitor that the patient was already receiving should be continued according to the standard schedule and dose of administration as determined by the treating physician. Immune Checkpoint Inhibitors include Ipilimumab (Melanoma) Nivolumab (Melanoma, Renal, NSCLC), Pembrolizumab (Melanoma, NSCLC), Atezolizumab (Bladder)

Study Details

Drugs called checkpoint inhibitors help the immune system fight cancer. When the effectiveness of these drugs wears off, it may be possible to renew their effectiveness by combining it with a special type of radiation therapy called stereotactic body radiation therapy (SBRT). SBRT is a commonly used type of radiation therapy that gives high dose radiation with high precision to tumors in 1-5 treatments. Radiation therapy, such as SBRT can also treat sites of metastases. The use of checkpoint inhibitors in combination with SBRT has been suggested to improve the immune response against cancer but has not been tested in a formal clinical trial. Up to three lesions can be treated with SBRT. This study only allows checkpoint inhibitors that are already approved by the Federal Drug Agency (FDA) for the treatment of your disease. All radiation therapy will be done on machines which are FDA approved.

Key Dates

Start date
Oct 1, 2018
Status verified
Oct 2025
Primary completion
Oct 31, 2026
Completion
Oct 31, 2026

Study Design

Enrollment
69 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Stereotactic Body Radiotherapy
    Image Guided, Stereotactic Body Radiotherapy (27 Gy over 3 fractions) to 1-3 lesions. Treatment with the checkpoint inhibitor will continue until progression at the discretion of the treating physician or unacceptable toxicity.

Primary Outcome Measure

evaluate overall response rate (ORR) [ Time Frame: 24 weeks ]

Locations (10)

FacilityCityStateZIPSite coordinators
Hartford HealthcareHartfordConnecticut06102-
Memorial Sloan Kettering Basking RidgeBasking RidgeNew Jersey07920-
Memorial Sloan Kettering MonmouthMiddletownNew Jersey07748-
Memorial Sloan Kettering BergenMontvaleNew Jersey07645-
Memorial Sloan Kettering CommackCommackNew York11725-
Memorial Sloan Kettering WestchesterHarrisonNew York10604-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Memorial Sloan Kettering Rockville CentreRockville CentreNew York11570-
Memorial Sloan Kettering NassauUniondaleNew York11553-
Lehigh Valley Health NetworkAllentownPennsylvania18103-

Find similar trials in Hartford, CT

By condition
Bladder cancerLung cancerKidney cancer
By specialty
OncologyUrologyLung oncologyLung disease
By research site
Hartford Healthcare· Hartford, CTMemorial Sloan Kettering Basking Ridge· Basking Ridge, NJMemorial Sloan Kettering Monmouth· Middletown, NJMemorial Sloan Kettering Bergen· Montvale, NJMemorial Sloan Kettering Commack· Commack, NYMemorial Sloan Kettering Westchester· Harrison, NY

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