Eligibility
18+
All Sexes
What conditions do you have?
Select
Study Summary
To find the recommended dose of OBX-115 in combination with acetazolamide that can be given to patients with metastatic melanoma previously treated with immune checkpoint inhibitors.
Eligible Conditions
- Melanoma
- Metastatic Melanoma
- Tumors
Treatment Effectiveness
Effectiveness Progress
Study Objectives
1 Primary · 0 Secondary · Reporting Duration: through completion of study, an average of 1 year
Year 1
To establish progression free survival (PFS)
Trial Safety
Safety Progress
Trial Design
1 Treatment Group
OBX-115 plus Acetazolamide
1 of 1
Experimental Treatment
30 Total Participants · 1 Treatment Group
Primary Treatment: OBX-115 plus Acetazolamide · No Placebo Group · Phase 1
OBX-115 plus AcetazolamideExperimental Group · 6 Interventions: OBX-115, Fludarabine Phosphate, Cyclophosphamide, Mesna, Acetazolamide, Furosemide · Intervention Types: Drug, Drug, Drug, Drug, Drug, Drug
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Fludarabine Phosphate
1997
Completed Phase 3
~2560
Cyclophosphamide
1995
Completed Phase 3
~4020
Mesna
2003
Completed Phase 2
~1410
Acetazolamide
2011
Completed Phase 4
~2760
Furosemide
2011
Completed Phase 4
~4170
Trial Logistics
Trial Timeline
Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: through completion of study, an average of 1 year
Closest Location: MD Anderson Cancer Center · Houston, TX
2004First Recorded Clinical Trial
75 TrialsResearching Melanoma
520 CompletedClinical Trials
Eligibility Criteria
Age 18+ · All Participants · 10 Total Inclusion Criteria
Mark “yes” if the following statements are true for you:You are male or female
• ANC ≥ 1000/mm3.
• Hemoglobin ≥ 8.
• Patients with liver metastases may have LFT ≤ 5.0 x ULN.
• Calculated creatinine clearance (Cockcroft-Gault) ≥ 50.
About The Reviewer
Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.
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Conditions
Cancer Related
Treatments