Radiation Therapy and Durvalumab, With or Without Tremelimumab, in Patients With Bladder Cancer

Part of paid clinical trials in San Francisco, California.

Sponsor
Terence Friedlander, MD
Study ID
NCT03150836
Phase
PHASE2
Status
Withdrawn

Conditions

Eligibility Criteria

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

Interventions

  • Durvalumab — DRUG
    All participants will receive durvalumab 1500 mg via IV infusion every 4 weeks for up to 13 doses.
  • Tremelimumab — DRUG
    Participants receiving Regimen B (safety lead-in or expansion cohort) will be administered tremelimumab 75 mg via IV infusion every 4 weeks for 1 cycle or 2 cycles.
  • Radiation Therapy — RADIATION
    In all arms of the study, participants will receive 5 fractions of radiation. The radiation dose will either be 6.6 Gy for a total dose of 33 Gy, or 6.0 Gy for a total dose of 30 Gy.

Study Details

This is a multi-site, randomized, prospective, open-label phase II study. Patients in this study will have localized (cT3-cT4), or metastatic bladder cancer with a symptomatic, intact primary bladder tumor. In this study, patients will undergo stereotactic body radiation therapy (SBRT) to the bladder tumor and will receive durvalumab with or without tremelimumab.

Key Dates

Start date
Oct 1, 2017
Status verified
Oct 2017
Primary completion
Sep 1, 2021
Completion
Sep 1, 2024

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Safety Lead-In, Regimen A1 Durvalumab + RT
    Durvalumab 1500 mg will be delivered via IV infusion q4wk. Radiation Therapy (RT) will be delivered beginning on day 8 ± 3 of durvalumab. RT (33Gy delivered as 6.6Gy x 5 fractions) should be completed within 14 days from the start of RT ideally over 5 consecutive days. Durvalumab 1500 mg q4wk will be continued to complete either 13 total cycles OR until disease progression, unacceptable toxicity, or patient withdrawal from study, whichever comes first.
  • Experimental: Safety Lead-In, Regimen A2 Durvalumab + RT
    In cohort A2 the dose of radiation will be decreased to a total dose of 30 Gy administered in 5 fractions of 6 Gy. Durvalumab 1500 mg will be delivered via IV infusion q4wk. Radiation Therapy (RT) will be delivered beginning on day 8 ± 3 of durvalumab. RT (30 Gy delivered as 6.0Gy x 5 fractions) should be completed within 14 days from the start of RT ideally over 5 consecutive days. Durvalumab 1500 mg q4wk will be continued to complete either 13 total cycles OR until disease progression, unacceptable toxicity, or patient withdrawal from study, whichever comes first.
  • Experimental: Safety Lead-In, Regimen B1 Durvalumab + Tremelimumab + RT
    Tremelimumab 75 mg will be administered via IV infusion q4wk for 2 cycles with durvalumab 1500 mg via IV infusion. Radiation Therapy (RT), at the optimal dose determined in the safety lead-in from Regimen A, will be delivered beginning on day 8 ± 3 of durvalumab. After two doses of tremelimumab and durvalumab, durvalumab 1500 mg q4wk will be continued to complete either 13 total cycles of durvalumab OR until disease progression, unacceptable toxicity, or patient withdrawal from study, whichever comes first.
  • Experimental: Safety Lead-In, Regimen B2 Durvalumab + Tremelimumab + RT
    Tremelimumab 75 mg will be administered via IV infusion q4wk for 1 cycle with durvalumab 1500 mg via IV infusion. Radiation Therapy (RT), at the optimal dose determined in the safety lead-in from Regimen A, will be delivered beginning on day 8 ± 3 of durvalumab. After one dose of tremelimumab and durvalumab, durvalumab 1500 mg q4wk will be continued to complete either 13 total cycles of durvalumab OR until disease progression, unacceptable toxicity, or patient withdrawal from study, whichever comes first.
  • Experimental: Expansion Cohort, Regimen A: Durvalumab + RT
    Durvalumab 1500 mg will be delivered via IV infusion q4wk. Radiation Therapy (RT) will be delivered beginning on day 8 ± 3 of durvalumab. RT (either 33Gy delivered as 6.6Gy x 5 fractions or 30 Gy delivered as 6.0 Gy x 5 fractions, as determined during the safety lead-in for Regimen B) should be completed within 14 days from the start of RT ideally over 5 consecutive days. Durvalumab 1500 mg q4wk will be continued to complete either 13 total cycles OR until disease progression, unacceptable toxicity, or patient withdrawal from study, whichever comes first.
  • Experimental: Expansion Cohort Regimen B: Durvalumab + Tremelimumab + RT
    Tremelimumab 75 mg will be administered via IV infusion q4wk for 1 or 2 cycles (as determined during the safety lead-in for Regimen B) with durvalumab 1500 mg via IV infusion. Radiation Therapy (RT), at the optimal dose determined in the safety lead-in from Regimen A, will be delivered beginning on day 8 ± 3 of durvalumab. After 1 or 2 doses of tremelimumab and durvalumab, durvalumab 1500 mg q4wk will be continued to complete either 13 total cycles of durvalumab OR until disease progression, unacceptable toxicity, or patient withdrawal from study, whichever comes first.

Primary Outcome Measure

Toxicity according to NCI CTCAE v. 4.03 criteria [ Time Frame: Over the duration of the study, which is estimated to be approximately 50 months. ]

Locations (1)

FacilityCityStateZIPSite coordinators
UCSF Helen Diller Family Comprehensive Cancer CenterSan FranciscoCalifornia94115-

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By condition
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By specialty
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By research site
UCSF Helen Diller Family Comprehensive Cancer Center· San Francisco, CA

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