IRX-2 Regimen and Durvalumab, for Incurable H&N Squamous Cell Carcinoma

Part of paid clinical trials in Tampa, Florida.

Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Study ID
NCT03381183
Phase
PHASE1
Status
Completed

Conditions

  • Hypopharynx Squamous Cell Carcinoma
  • Larynx Squamous Cell Carcinoma
  • Metastatic Squamous Cell Carcinoma
  • Oral Cavity Squamous Cell Carcinoma
  • Oropharynx Squamous Cell Carcinoma
  • Paranasal Sinus Squamous Cell Carcinoma
  • Squamous Cell Carcinoma
  • Squamous Cell Carcinoma of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Durvalumab — DRUG
    Phase 1 and Phase 2: 1500 mg every 4 weeks (Q4wks).
  • IRX-2 Regimen — DRUG
    Phase 1 and Phase 2 - Every 12 weeks - IRX-2 Regimen: Cyclophosphamide 300 mg/m\^2 - intravenously. IRX-2: 460 units daily (4 injections of 115 units).

Study Details

The purpose of this study is to see if the IRX-2 regimen and Durvalumab, will have a tolerable safety profile and will increase the intratumoral immune profile compared with the pretreatment tumors.

Key Dates

Start date
Aug 21, 2019
Status verified
Dec 2025
Primary completion
May 12, 2022
Completion
Jun 30, 2023

Study Design

Enrollment
19 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 - Dose Escalation
    Six patients will be enrolled at Dose Level 1 with IRX-2 230 units/day in combination with cyclophosphamide and durvalumab and treated sequentially at least 1 week apart. If less than 2 out of 6 patients have DLTs in Dose Level 1, the dose will be escalated to administration of IRX-2 460 Units/day in combination with cyclophosphamide and durvalumab as Dose Level 2. If 2 of 6 patients have DLTs, stop accrual and re-evaluate. In the next safety phase, six patients at IRX-2 460 Units/day in combination with cyclophosphamide and durvalumab will be enrolled and treated sequentially (at least 1 week apart). If DLT occurs in less than 2 of 6 patients during the first 6 weeks of treatment, enrollment can continue in the dose expansion phase at Dose Level 2. If DLT is observed in 2 of 6 patients, accrual will be stopped and Dose Level 1 will resume in the dose expansion phase.
  • Experimental: Phase 2 - Dose Expansion
    14 patients will be enrolled at the recommended dose level from the dose finding phase for a total enrollment of 20 patients; however, investigators will replace patients with any missing tumor sample collection and continue enrollment until there are at least 20 pre- and post-treatment paired tumors (i.e. minimum 2 of 3 tumors per patient). The 6 patients treated at the recommended dose in the dose finding phase of the study will be counted as a part of the dose expansion patient population,

Primary Outcome Measure

Phase 1 - Maximum Tolerated Dose (MTD) [ Time Frame: Up to 12 months ]

Locations (1)

FacilityCityStateZIPSite coordinators
H. Lee Moffitt Cancer Center and Research InstituteTampaFlorida33612-

Find similar trials in Tampa, FL

By condition
Skin cancer
By specialty
OncologySkin cancerDermatology
By research site
H. Lee Moffitt Cancer Center and Research Institute· Tampa, FL

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