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CAR T-cell Therapy
Engineered TILs + Acetazolamide for Melanoma
Phase 1
Waitlist Available
Led By Rodabe N Amaria, MD
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Male or female patients age ≥ 18 at the time of signing ICF
Patient has a pathologically confirmed diagnosis of metastatic melanoma that is unresectable stage III or stage IV and has lesion(s) amenable to resection for the generation of TILs and at least one separate lesion for RECIST v1.1 response assessment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up through completion of study, an average of 1 year
Awards & highlights
Study Summary
This trial is testing a new combination drug therapy for melanoma that has spread to other parts of the body and has not responded to other treatments.
Who is the study for?
Adults over 18 with stage III or IV metastatic melanoma that's not removable by surgery and have failed immune checkpoint inhibitor therapy can join. They need a tumor for TIL generation, another for response assessment, proper organ function tests, no severe heart issues, and must use birth control. Excluded are those with uncontrolled illnesses, recent chemotherapy or live vaccines, certain infections like HIV/HCV requiring treatment, brain metastases of melanoma, serious cardiac conditions within the last 6 months, other cancers in the last 2 years (with exceptions), significant allergies to sulfa drugs or on chronic acetazolamide.Check my eligibility
What is being tested?
This Phase I trial is testing OBX-115 combined with acetazolamide to find a safe dose for patients with metastatic melanoma who've already tried immune checkpoint inhibitors. It also includes pre-treatment drugs like cyclophosphamide and fludarabine phosphate to prepare the body ('lymphodepletion') before introducing OBX-115.See study design
What are the potential side effects?
Possible side effects include reactions related to infusion such as fever or chills; blood count changes leading to increased infection risk; fatigue; liver enzyme elevations indicating potential liver damage; nausea and vomiting from digestive system irritation; kidney function changes due to creatinine clearance alterations.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have advanced melanoma with tumors that can be used to generate TILs and at least one tumor for tracking treatment response.
Select...
I am fully active or can carry out light work.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ through completion of study, an average of 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~through completion of study, an average of 1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Incidence and nature of dose-limiting toxicities (DLTs) during the first 28 days after OBX-115 + acetazolamide administration as assessed by CTCAE version 5.0. Incidence and severity of AEs and SAEs after OBX-115 + acetazolamide administration.
Trial Design
1Treatment groups
Experimental Treatment
Group I: OBX-115 plus AcetazolamideExperimental Treatment6 Interventions
Participants will receive chemotherapy to prepare your body for the study drug combination, then you will receive OBX-115 and acetazolamide.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Acetazolamide
2011
Completed Phase 4
~2910
Cyclophosphamide
1995
Completed Phase 3
~3770
Furosemide
2015
Completed Phase 4
~4240
Mesna
2003
Completed Phase 2
~1380
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,325 Total Patients Enrolled
9 Trials studying Tumors
8,541 Patients Enrolled for Tumors
Rodabe N Amaria, MDPrincipal InvestigatorM.D. Anderson Cancer Center
2 Previous Clinical Trials
93 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not used immune checkpoint inhibitors as a temporary treatment.I do not have a fever or an active infection needing treatment.You have a severe allergy to sulfa medications that could be life-threatening.I have a history of interstitial lung disease.I can understand and agree to the study's procedures.You have had a serious autoimmune disease in the past.I am on a low dose (≤10 mg/day) of steroids for an immune system condition.My melanoma has spread to my brain or spinal cord.I regularly take medication for fluid build-up or eye pressure.I have tested positive for herpes simplex virus but can be treated before starting my cancer treatment.I have had an organ or bone marrow transplant.I am currently receiving treatment for HIV, hepatitis B, or hepatitis C.I have side effects from past treatments, but they are not severe except for possible nerve issues, hair loss, or skin changes.I do not have serious heart problems like recent heart attacks or severe heart failure.I am fully active or can carry out light work.I am 18 years old or older.I have not received any live vaccines in the last 30 days.I have advanced melanoma with tumors that can be used to generate TILs and at least one tumor for tracking treatment response.I have had another type of cancer in the last 2 years, but it was either skin, thyroid, or cervical cancer treated with the intent to cure.I have cancer that didn't respond to specific immune treatments and followed standard care.I haven't had chemotherapy in the last 2 weeks.I haven't taken cancer drugs or chemotherapy within the last 2 weeks.I have active CMV or EBV infection but can consult an infectious disease doctor for treatment.
Research Study Groups:
This trial has the following groups:- Group 1: OBX-115 plus Acetazolamide
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many individuals have been enrolled for this experiment?
"Affirmative. Clinicaltrials.gov provides information that this clinical trial is currently recruiting participants, with a first posting date of September 7th 2022 and last update on the same day. The research will require 30 individuals from one study centre to enrol in total."
Answered by AI
Are people still being accepted to join this investigation?
"Correct. According to the information hosted on clinicaltrials.gov, this medical trial is actively seeking enrolment of participants and was recently updated as of September 7th 2022. Currently, 30 patients are required in a single location for the study's completion."
Answered by AI
What health risks are potentially posed by OBX-115?
"Our team at Power has assessed the safety of OBX-115 to be a 1, as this is currently only in Phase 1 clinical trial with limited data on efficacy and security."
Answered by AI
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