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

Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-70
SponsorIovance Biotherapeutics, Inc.

About this trial

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).

Eligibility criteria

Qualifiers

Participants must have a confirmed diagnosis of Stage IIIC, IIID, or IV unresectable or metastatic melanoma or Stage III or IV NSCLC.

Cohort 1 (Melanoma): Participants who have progressed within 12 weeks of last dose of anti-PD-1/PD-L1 blocking antibody and received BRAF/MEK inhibitor in those with BRAF mutations.

those without oncogene-driven tumors: Have progressed within 12 weeks after last dose of anti-PD-1/PD-L1 blocking antibody

platinum doublet chemotherapy

Disqualifiers

Participants who have melanoma of uveal/ocular origin.

Participants who have symptomatic untreated brain metastases.

Participants who have had a history of allogeneic organ transplant or any form of cell therapy involving prior conditioning chemotherapy within the past 20 years.

Participants who require systemic steroid therapy 10 mg/day prednisone or another steroid equivalent dose.

Trial design

Treatments tested in this trial

  • IOV-4001

Treatment groups

53 Participants
are divided into 2 treatment groups

Sponsors and collaborators