Phase 2b of RAPA-201 Cell Therapy in Post-PD-(L)-1 Melanoma
NCT06708455 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 65
Last updated 2026-03-19
Summary
The protocol is a Simon's 2-stage, non-randomized, open label, multi-site, phase 2 trial for patients with advanced metastatic, recurrent and unresectable malignant melanoma that has recurred or relapsed after prior anti-PD-(L)1 therapy.
Conditions
- Malignant Melanoma With Metastasis
- Malignant Melanoma
- Malignant Melanoma Stage IIIc
- Malignant Melanoma Stage IV
Interventions
- BIOLOGICAL
-
RAPA-201 Rapamycin Resistant T Cells
Autologous Rapamycin-Resistant Th1/Tc1 Cells
- DRUG
-
Chemotherapy Prior to RAPA-201 Therapy
Carboplatin + Paclitaxel Regimen (CP Regimen)
Sponsors & Collaborators
-
Rapa Therapeutics LLC
lead INDUSTRY
Principal Investigators
-
Daniel Fowler, M.D. · Rapa Therapeutics
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2027-03-01
- Primary Completion
- 2029-03-01
- Completion
- 2029-09-30
- FDA Drug
- Yes
Countries
- United States
Study Locations
More Related Trials
-
Taxoprexin® Treatment for Advanced Eye Melanoma
NCT00244816 ·Status: COMPLETED ·Phase: PHASE2
-
Tipifarnib in Treating Patients With Metastatic Malignant Melanoma
NCT00060125 ·Status: COMPLETED ·Phase: PHASE2
-
Dose Escalation and Cohort Expansion of Safety and Tolerability Study of Intratumoral rAd.CD40L (ISF35) in Combination of Systemic Pembrolizumab in Patients With Refractory Metastatic Melanoma
NCT02719015 ·Status: WITHDRAWN ·Phase: PHASE1/PHASE2
-
Efficacy and Safety of Talimogene Laherparepvec Neoadjuvant Treatment Plus Surgery Versus Surgery Alone for Melanoma
NCT02211131 ·Status: COMPLETED ·Phase: PHASE2
-
RADVAX™: A STRATIFIED PHASE I/II DOSE ESCALATION TRIAL OF HYPOFRACTIONATED RADIOTHERAPY FOLLOWED BY IPILIMUMAB IN METASTATIC MELANOMA
NCT01497808 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Molecularly Targeted Therapy in Treating Patients With BRAF Wild-type Melanoma That is Metastatic
NCT02094872 ·Status: COMPLETED ·Phase: PHASE2
-
Taxoprexin Treatment for Advanced Skin Melanoma
NCT00249262 ·Status: COMPLETED ·Phase: PHASE2
-
Phase I and Consecutive Phase II, Two-arm, Randomized Multi-center Trial in Patients With Advanced Melanoma
NCT01614301 ·Status: UNKNOWN ·Phase: PHASE1/PHASE2
-
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
-
Biopsy- and Biology-driven Optimization of Targeted Therapy in Subjects With Advanced Melanoma
NCT02410863 ·Status: TERMINATED ·Phase: PHASE2
-
Evaluation of Photosensitivity in Dabrafenib or Vemurafenib Treated Metastatic Melanoma Patients - a Phase IIa/IIb Study
NCT02052193 ·Status: TERMINATED ·Phase: PHASE2
-
Phase II Biomarker Study Comparing the Combination of BRAF Inhibitor Dabrafenib With MEK Inhibitor Trametinib Versus the Combination After Monotherapy With Dabrafenib or Trametinib
NCT02314143 ·Status: TERMINATED ·Phase: PHASE2
-
SUPRAME-ACTengine® IMA203 vs. Investigator's Choice of Treatment in Previously Treated, Unresectable or Metastatic Cutaneous Melanoma
NCT06743126 ·Status: RECRUITING ·Phase: PHASE3
-
Talimogene Laherparepvec With Pembrolizumab in Melanoma Following Progression on Prior Anti-PD-1 Based Therapy (MASTERKEY-115) (Mk-3475-A07/KEYNOTE-A07).
NCT04068181 ·Status: COMPLETED ·Phase: PHASE2
-
Phase II Study of Abraxane Plus Ipilimumab in Patients With Metastatic Melanoma
NCT01827111 ·Status: COMPLETED ·Phase: PHASE2
-
Binimetinib and Nivolumab for the Treatment of Locally Advanced Unresectable or Metastatic BRAF V600 Wildtype Melanoma
NCT04375527 ·Status: TERMINATED ·Phase: PHASE2
-
Phase II Trial of Stereotactic Body Radiotherapy Followed by Ipilimumab in Treating Patients With Stage IV Melanoma
NCT01970527 ·Status: TERMINATED ·Phase: PHASE2
-
CBL0137 in Treating Patients With Advanced Extremity Melanoma or Sarcoma
NCT03727789 ·Status: TERMINATED ·Phase: PHASE1
-
A Phase III Study to Test the Benefit of a New Kind of Anti-cancer Treatment in Patients With Melanoma, After Surgical Removal of Their Tumor
NCT00796445 ·Status: TERMINATED ·Phase: PHASE3
-
Safety and Efficacy in Participants With Metastatic BRAF-mutant Melanoma Treated With Encorafenib With and Without Binimetinib in Combination With Nivolumab and Low-dose Ipilimuma
NCT04655157 ·Status: TERMINATED ·Phase: PHASE1/PHASE2
-
Study of the Efficacy of Intratumoral L19IL2 or L19TNF or L19IL2/L19TNF, in Combination with Pembrolizumab, in Unresectable Melanoma Patients
NCT06284590 ·Status: RECRUITING ·Phase: PHASE2
-
A Clinical Study of the Safety and Activity of the Investigational Cell Therapy NEO-PTC-01 in Patients With Advanced Melanoma
NCT04625205 ·Status: TERMINATED ·Phase: PHASE1
-
Study of Cemiplimab Alone or in Combination With Fianlimab and/or Other Experimental Agents in Adult Participants With Peri-operative Stage III/IV Cutaneous Squamous Cell Carcinoma (CSCC)
NCT06384820 ·Status: WITHDRAWN ·Phase: PHASE2
-
Ipilimumab With or Without Dabrafenib, Trametinib, and/or Nivolumab in Treating Patients With Melanoma That Is Metastatic or Cannot Be Removed by Surgery
NCT01940809 ·Status: TERMINATED ·Phase: PHASE1
-
Troriluzole or Placebo Plus Ipi Plus Nivo in Mel Brain Mets
NCT04899921 ·Status: TERMINATED ·Phase: PHASE2