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.
Male or female patients ≥ 18 years of age.
Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and an estimated life expectancy of ≥ 3 months.
Patients with unresectable or metastatic melanoma (Stage IIIc or Stage IV).
Prior to enrollment, documented refractory status to the most recent regimen, which must include an anti-PD-(L)1 monoclonal antibody, as defined by lack of response after at least two cycles of therapy or relapse within 12-months of initiation of the anti-PD- (L)1-containing therapy.
Other active malignancy (except non-melanoma skin cancer).
Life expectancy < 3 months.
Seropositivity for HIV, hepatitis B, or hepatitis C, unless such conditions are in stable condition using adequate treatment.
Uncontrolled hypertension.
Single group
RAPA-201 Rapamycin Resistant T Cells
Biological/VaccineAutologous Rapamycin-Resistant Th1/Tc1 Cells
Chemotherapy Prior to RAPA-201 Therapy
DrugCarboplatin + Paclitaxel Regimen (CP Regimen)
Efficacy of RAPA-201 Cell Therapy
In an intent-to-treat (ITT) manner, the efficacy of RAPA-201 cell therapy will be determined by overall response rate (ORR) in metastatic melanoma patients with progressive disease after anti-PD-(L)1 therapy, as assessed by the independent review committee (IRC) per iRECIST v1.1.
Characterize RAPA-201 Efficacy
To further characterize RAPA-201 efficacy by measurement of duration of response (DOR; as measured in days), disease-control-rate (DCR; as measured in days ), progression-free-survival (PFS), and overall survival (OS; as measured in days), as assessed by the IRC and Site Investigator (iRECIST v1.1).
Safety of RAPA-201 Cell Therapy
Safety, as measured by determination of the number and grade of any adverse event attributable to the RAPA-201 Investigational Product \[using the CTCAE v4.0 nomenclature\]
Quality of Life (QOL)
To evaluate effect of therapy on quality of life (QOL) using the Short Form-36 Survey. The Short-Form 36 Survey that will be utilized uses a scale of 0-to-100, with higher scores indicating a better outcome.
Immune Reconstitution
To characterize the immune reconstitution pattern in recipients of RAPA-201 therapy to better understand the therapeutic mechanism and lead to biomarker or predictive tests. Immune reconstitution will be quantified by determination of the absolute lymphocyte count (ALC) at the time of study entry, after RAPA-201 therapy, and then at the patient's last study visit.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
