A Study to Investigate the Efficacy and Safety of an Infusion of IOV-4001 in Adult Participants With Unresectable or Metastatic Melanoma or Stage III or IV Non-small-cell Lung Cancer

Part of paid clinical trials in Los Angeles, California.

Sponsor
Iovance Biotherapeutics, Inc.
Study ID
NCT05361174
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Metastatic Melanoma
  • Stage III Non-small Cell Lung Cancer
  • Stage IV Non-small Cell Lung Cancer
  • Unresectable Melanoma

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • IOV-4001 — BIOLOGICAL
    A tumor sample is resected from each participant and cultured ex-vivo to manufacture IOV-4001. After lymphodepleting chemotherapy including cyclophosphamide and fludarabine, participant is infused with IOV-4001, and followed by IL-2.

Study Details

This is a study to investigate the efficacy and safety of an infusion of IOV-4001 in adult participants with unresectable or metastatic melanoma or advanced non-small-cell lung cancer (NSCLC).

Key Dates

Start date
Jul 20, 2022
Status verified
Jun 2026
Primary completion
Sep 30, 2027
Completion
Sep 30, 2029

Study Design

Enrollment
53 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort 1
    Participants with unresectable or metastatic melanoma
  • Experimental: Cohort 2
    Participants with Stage III or IV non-small-cell lung cancer

Primary Outcome Measure

Phase I: Safety of IOV-4001 [ Time Frame: Up to 1 Year or depending on when the recommended phase 2 dose is determined ]

Central Contacts

Locations (11)

FacilityCityStateZIPSite coordinators
The Angeles Clinic and Research InstituteLos AngelesCalifornia90025-
Sylvester Comprehensive Cancer CenterMiamiFlorida33136-
Orlando Health Cancer InstituteOrlandoFlorida32610-
Moffitt Cancer CenterTampaFlorida33612-
The University of Kansas Cancer CenterWestwoodKansas66205-
University of LouisvilleLouisvilleKentucky40202-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Weill Medical College of Cornell UniversityNew YorkNew York10022-
University of CincinnatiCincinnatiOhio45219-
UPMC Hillman Cancer CenterPittsburghPennsylvania15232-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Los Angeles, CA

By condition
Melanoma
By specialty
OncologySkin cancerDermatology
By research site
The Angeles Clinic and Research Institute· Los Angeles, CASylvester Comprehensive Cancer Center· Miami, FLOrlando Health Cancer Institute· Orlando, FLMoffitt Cancer Center· Tampa, FLThe University of Kansas Cancer Center· Westwood, KSUniversity of Louisville· Louisville, KY

Related Studies