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Alkylating agents
Evofosfamide plus Ipilimumab for Pancreatic Cancer
Phase 1
Waitlist Available
Led By David Hong, MD
Research Sponsored by Threshold Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 2 years
Awards & highlights
No Placebo-Only Group
Summary
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.
Eligible Conditions
- Prostate Cancer
- Pancreatic Cancer
- Melanoma
- Squamous Cell Carcinoma
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ approximately 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 2 years
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Recommended phase 2 dose (RP2D) determined after maximally tolerated dose is set and four dose expansion cohorts have evaluable data
Secondary study objectives
Change from tumor diameter baseline
Maximum tolerated dose (MTD) of this therapy based on number of dose limiting toxicities that occur during the dose escalation phase
Number of participants with treatment related adverse events
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
1Treatment groups
Experimental Treatment
Group I: Evofosfamide plus IpilimumabExperimental Treatment2 Interventions
Ipilimumab to be administered at same dose. Evofosfamide dose to be determined during duration of trial
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Ipilimumab
FDA approved
Evofosfamide
Not yet FDA approved
Find a Location
Who is running the clinical trial?
Threshold PharmaceuticalsLead Sponsor
32 Previous Clinical Trials
3,796 Total Patients Enrolled
M.D. Anderson Cancer CenterOTHER
3,069 Previous Clinical Trials
1,802,615 Total Patients Enrolled
David Hong, MDPrincipal InvestigatorM.D. Anderson Cancer Center
7 Previous Clinical Trials
2,928 Total Patients Enrolled
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