Phase I, Open-Label, Study of Tumor Infiltrating Lymphocytes Engineered With Membrane Bound IL15 Plus Acetazolamide in Adult Patients With Metastatic Melanoma
NCT05470283 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2026-04-16
Summary
The goal of this clinical research study is 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. The safety and tolerability of the study drug combination will also be studied.
Conditions
- Tumor
- Metastatic Melanoma
- Melanoma
Interventions
- DRUG
-
OBX-115
Given by IV
- DRUG
-
Acetazolamide
Given by PO
- DRUG
-
Given by IV
- DRUG
-
Furosemide
Given by IV
- DRUG
-
Mesna
Given by IV
- DRUG
-
Fludarabine Phosphate
Given by IV
Sponsors & Collaborators
-
M.D. Anderson Cancer Center
lead OTHER
Principal Investigators
-
Rodabe N Amaria, MD · M.D. Anderson Cancer Center
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-09-07
- Primary Completion
- 2027-04-01
- Completion
- 2027-04-01
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Pembrolizumab, Standard Chemotherapy, Tumor Infiltrating Lymphocytes, and High- or Low-Dose Aldesleukin in Treating Patients With Metastatic Melanoma
NCT02500576 ·Status: COMPLETED ·Phase: PHASE2
-
Study of CBL0137 in Combination With Ipilimumab and Nivolumab Therapy in Melanoma
NCT05498792 ·Status: RECRUITING ·Phase: EARLY_PHASE1
-
APX005M in Combination With Systemic Pembrolizumab in Patients With Metastatic Melanoma
NCT02706353 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
NCT06743126 ·Status: RECRUITING ·Phase: PHASE3
-
SB-715992 in Treating Patients With Metastatic or Recurrent Malignant Melanoma
NCT00095953 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation Study of MLN4924 in Adults With Melanoma
NCT01011530 ·Status: COMPLETED ·Phase: PHASE1
-
Phase I Safety and Dosimetry Study in Patients With Confirmed Metastatic Melanoma
NCT00747825 ·Status: TERMINATED ·Phase: PHASE1
-
Opdualag vs. Cemiplimab/Fianlimab in Relation to the Immunological Response in Tumor and Peripheral Blood in Unresectable or Metastatic Melanoma
NCT07223411 ·Status: RECRUITING
-
Metronomic Cyclophosphamide With Pembrolizumab in Checkpoint Inhibitor Refractory Melanoma
NCT06771544 ·Status: RECRUITING ·Phase: PHASE2
-
Ipilimumab + Temozolomide in Metastatic Melanoma
NCT01119508 ·Status: COMPLETED ·Phase: PHASE2
-
Taxoprexin® Treatment for Advanced Eye Melanoma
NCT00244816 ·Status: COMPLETED ·Phase: PHASE2
-
Phase 1b Safety Study of CMB305 in Patients With Locally Advanced, Relapsed, or Metastatic Cancer Expressing NY-ESO-1
NCT02387125 ·Status: TERMINATED ·Phase: PHASE1
-
Safety and Efficacy Study of Pembrolizumab (MK-3475) in Chinese Participants With Locally Advanced or Metastatic Melanoma (MK-3475-151/KEYNOTE-151)
NCT02821000 ·Status: COMPLETED ·Phase: PHASE1
-
Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of Investigational Treatments in Combination With Standard of Care Immune Checkpoint Inhibitors in Participants With Advanced Melanoma
NCT02723006 ·Status: TERMINATED ·Phase: PHASE1
-
Study of the Combination of Anti-OX40 and Ipilimumab in Patients With Metastatic Melanoma
NCT01689870 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
RTA 408 Capsules in Patients With Melanoma - REVEAL
NCT02259231 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Axitinib in Treating Patients With Melanoma That is Metastatic or Cannot Be Removed by Surgery
NCT01533948 ·Status: TERMINATED ·Phase: PHASE2
-
FLX475 in Combination With Ipilimumab in Advanced Melanoma
NCT04894994 ·Status: TERMINATED ·Phase: PHASE2
-
Low Dose Ipilimumab With Pembrolizumab in Treating Patients With Melanoma That Has Spread to the Brain
NCT03873818 ·Status: COMPLETED ·Phase: PHASE2
-
Chemotherapy, Irradiation, Cell Infusions, and Interleukin-2 to Treat Metastatic Melanoma
NCT00314106 ·Status: COMPLETED ·Phase: PHASE2
-
Intratumoral Injection of LTX-315 in Combination With Pembrolizumab in Advanced Melanoma
NCT04796194 ·Status: COMPLETED ·Phase: PHASE2
-
Evaluate Efficacy, Immunological Response of Intratumoral/Intralesional Oncolytic Virus (OBP-301) in Metastatic Melanoma
NCT03190824 ·Status: UNKNOWN ·Phase: PHASE2
-
Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With Metastatic Melanoma of the Eye That Cannot Be Removed By Surgery
NCT00738361 ·Status: COMPLETED ·Phase: PHASE2
-
Study of MDX-010 in Subjects With Unresectable Stage III or Stage IV Malignant Melanoma
NCT00729950 ·Status: COMPLETED ·Phase: PHASE1
-
Phase II Study of Nivolumab in Combination With Relatlimab in Patients With Active Melanoma Brain Metastases
NCT05704647 ·Status: RECRUITING ·Phase: PHASE2