Placebo-Controlled Trial of IFx-Hu2.0 Followed By Pembrolizumab In Checkpoint Inhibitor Naïve Participants With Advanced Or Metastatic Merkel Cell Carcinoma

Conditions

• Advanced Or Metastatic Merkel Cell Carcinoma

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• IFx-Hu2.0 — DRUG
  Therapeutic Classification: • Innate immune agonist Route of Administration: • Intralesional
• Placebo — DRUG
  Route of Administration: • Intralesional
• Pembrolizumab — DRUG
  Therapeutic Classification: • Immunotherapy (Immune checkpoint inhibitor) Route of administration: • Intravenous (IV) infusion

Study Details

This Phase 2/3, multicenter, randomized, double-blind, placebo-controlled trial will evaluate the Objective Response Rate (ORR) of IFx-Hu2.0 as an adjunctive therapy to pembrolizumab in adult participants (≥18 years) with advanced or metastatic Merkel Cell Carcinoma. A total of 118 participants will be randomized to receive either IFx-Hu2.0 or placebo via intralesional injection in a single lesion, followed by pembrolizumab.

Key Dates

Start date

Dec 11, 2025

Status verified

Apr 2026

Primary completion

Mar 31, 2027

Completion

Dec 30, 2032

Study Design

Enrollment

118 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Treatment Arm
  Participants randomized to the treatment arm will receive IFx-Hu2.0 (0.1 mg) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered intravenously (IV) on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the pembrolizumab dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until progressive disease (PD), unacceptable immune-related toxicities, or for a maximum duration of 2 years.
• Placebo Comparator: Control Arm
  Participants randomized to the control arm will receive placebo (0.9% Sodium Chloride Injection, USP) via intralesional injection in a single lesion once per week for 3 consecutive weeks. Pembrolizumab (200 mg) will be administered IV on Day 1, followed by administration every 3 weeks during the first year of treatment. In the second year, the dose will be 400 mg every 6 weeks. Pembrolizumab treatment will continue until PD, unacceptable immune-related toxicities, or for a maximum duration of 2 years.

Primary Outcome Measure

Objective response rate (ORR) [ Time Frame: 12 weeks post-treatment initiation and confirmed on a second response assessment at least 28 days after the initial response assessment ]

Central Contacts

• Amit Pande, MD
  8138756600
  [email protected]

Locations (18)

Find similar trials in Los Angeles, CA

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• IFx-Hu2.0 As An Adjunctive Therapy To Pembrolizumab In Advanced Or Metastatic Merkel Cell Carcinoma (MCC)
  PHASE1 · Recruiting · TuHURA Biosciences, Inc. · Tampa, Florida