Study of Monalizumab and Cetuximab in Patients With Recurrent or Metastatic Squamous Cell Carcinoma of the Head and Neck

Part of paid clinical trials in La Jolla, California.

Sponsor
Innate Pharma
Study ID
NCT02643550
Phase
PHASE1/PHASE2
Status
Completed

Conditions

  • Head and Neck Neoplasms

Eligibility Criteria

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

Interventions

  • Monalizumab — BIOLOGICAL
  • Cetuximab — BIOLOGICAL
  • Anti-PD(L)1 — BIOLOGICAL

Study Details

The objective of this study is to evaluate in a 3 +3 design, the safety of escalating doses of Monalizumab given IV in combination with cetuximab in patients who have received prior systemic regimen(s) for recurrent and/or metastatic squamous cell carcinoma of the head and neck (SCCHN). Cohorts expansion will evaluate antitumor activity of monalizumab and cetuximab with or without anti-PD(L)1

Key Dates

Start date
Dec 31, 2015
Status verified
May 2023
Primary completion
Mar 28, 2023
Completion
Mar 28, 2023

Study Design

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

Arms

  • Experimental: Dose escalation
    Dose escalation of monalizumab in combination with cetuximab
  • Experimental: Expansion cohort 1
    monalizumab + cetuximab expansion cohort
  • Experimental: Expansion cohort 2
    monalizumab + cetuximab expansion cohort in patients with prior exposure to PD-(L)1 blockers
  • Experimental: Expansion cohort 3
    monalizumab + cetuximab + anti-PD(L)1

Primary Outcome Measure

Occurrence of Dose Limiting Toxicities (DLT) in the dose escalation part of the study [ Time Frame: within 4 weeks after first administration ]

Locations (9)

FacilityCityStateZIPSite coordinators
University of California, Moores Cancer CenterLa JollaCalifornia--
Stanford Cancer CenterStanfordCalifornia94305-
University of ChicagoChicagoIllinois60637-
University of Maryland, Greenebaum Comprehensive Cancer CenterBaltimoreMaryland--
Washington University School of MedicineSt LouisMissouri--
Icahn School of Medicine at Mount SinaïNew YorkNew York10029-
Fox Chase Cancer CenterPhiladelphiaPennsylvania19111-
University of PennsylvaniaPhiladelphiaPennsylvania19104-
Vanderbilt University Medical CenterNashvilleTennessee--

Find similar trials in La Jolla, CA

By research site
University of California, Moores Cancer Center· La Jolla, CAStanford Cancer Center· Stanford, CAUniversity of Chicago· Chicago, ILUniversity of Maryland, Greenebaum Comprehensive Cancer Center· Baltimore, MDWashington University School of Medicine· St Louis, MOIcahn School of Medicine at Mount Sinaï· New York, NY

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