Immunotherapy Study of Evofosfamide in Combination With Ipilimumab

Part of paid clinical trials in Houston, Texas.

Sponsor
Threshold Pharmaceuticals
Study ID
NCT03098160
Phase
PHASE1
Status
Unknown

Conditions

Eligibility Criteria

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

Interventions

  • Evofosfamide — DRUG
    Evofosfamide given on day one and in combination with Ipilimumab on day 8 of the first two cycles, Ipilimumab given alone on day 8 of last two cycles for a total of four 21 day dosing cycles.
  • Ipilimumab — DRUG
    Evofosfamide given on day one and in combination with Ipilimumab on day 8 of the first two cycles, Ipilimumab given alone on day 8 of last two cycles for a total of four 21 day dosing cycles.

Study Details

An immunotherapy study combining ipilimumab and evofosfamide for the treatment of patients with confirmed metastatic or locally advanced prostate cancer, metastatic pancreatic cancer, melanoma or human papillomavirus (HPV) negative squamous cell carcinoma of head and neck that have failed to respond to standard therapy, progressed despite standard therapy, for which standard therapy does not offer the potential for increased survival.

Key Dates

Start date
May 10, 2017
Status verified
Oct 2017
Primary completion
Jan 31, 2019
Completion
Apr 30, 2019

Study Design

Enrollment
69 participants (estimated)
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Evofosfamide plus Ipilimumab
    Ipilimumab to be administered at same dose. Evofosfamide dose to be determined during duration of trial

Primary Outcome Measure

Recommended phase 2 dose (RP2D) determined after maximally tolerated dose is set and four dose expansion cohorts have evaluable data [ Time Frame: Approximately 8-12 months ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Ly Nguyen
[email protected]
713-563-2169
Dwana Sanders
[email protected]

Find similar trials in Houston, TX

By condition
MelanomaPancreatic cancerProstate cancer
By specialty
OncologySkin cancerDermatologyGI oncologyProstate oncologyMen's healthUrology
By research site
MD Anderson Cancer Center· Houston, TX

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