Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma

NCT06046482 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: 2022-0903NCI-2023-07199
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To learn if magrolimab, along with a combination of commercially-available drugs (cetuximab, pembrolizumab, and docetaxel) can help to control HNSCC in combination with other drugs. The safety of magrolimab will also be studied.

Conditions

Head Neck; Squamous Cell Carcinoma of Head and Neck

Outcome Measures

Primary Outcomes (1)

• Objective Response Rate (ORR)

  Objective Response Rate (ORR) per RECIST v1.1. Per Response Evaluation Criteria in Solid Tumors Criteria (RECIST v.1.1) for target lesions and assessed by CT or MRI: Complete Response (CR), disappearance of all target lesions; Partial Response (PR), \>= 30% decrease in the sum of the longest diameter of target lesions; Stable Disease (SD), neither sufficient shrinkage to qualify for PR nor sufficient growth to qualify for PD; Progressive Disease (PD), \>= 20% increase in the sum of the longest diameter with an absolute increase of at least 5 mm or the appearance of new lesions

  140 days

Secondary Outcomes (3)

• Number of Treatment-Emergent Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0

  145 days

• Duration of Response (DOR)

  2 weeks and 1 day

• Number of Participants With Progression Free Survival (PFS) and/or Death

  4 months and 4 days

Study Arms (2)

Cohort A

EXPERIMENTAL

Participants will receive magrolimab and cetuximab along with pembrolizumab.

Drug: Pembrolizumab; Drug: Magrolimab; Drug: cetuximab

Cohort B

EXPERIMENTAL

Participants will receive magrolimab and cetuximab along with docetaxel.

Drug: Magrolimab; Drug: cetuximab; Drug: Docetaxel

Interventions

Pembrolizumab DRUG

Given by IV (vein)

Also known as: KEYTRUDA®

Cohort A

Magrolimab DRUG

Given by IV (vein)

Cohort A; Cohort B

cetuximab DRUG

Given by IV (vein)

Also known as: ERBITUX

Cohort A; Cohort B

Docetaxel DRUG

Given by IV (vein)

Cohort B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient must have a diagnosis of recurrent or metastatic oropharynx, oral cavity, hypopharynx, or larynx squamous cell carcinoma (HNSCC), not amenable to curative-intent local therapy with known PD-L1 CPS determined by an FDA-approved test. Patients with unknown primary squamous cell carcinoma presumed from the head and neck are also eligible upon discussion with study principal investigator.
• Patient has provided informed consent.
• Patient is willing and able to comply with clinic visits and procedures outlined in the study protocol.
• Male or female ≥ 18 years of age
• ECOG performance status of 0 or 1
• Laboratory measurements, blood counts:
• Absolute neutrophil count ≥ 1.2 x 109/mL
• Platelets ≥ 100 x 109/mL
• Laboratory measurements, renal function:
• Serum creatinine ≤ 1.5 x upper limit of normal (ULN) or if elevated, a calculated glomerular filtration rate \> 40 mL/min/1.73m2 per CKD-EPI equation.
• Laboratory measurements, hepatic function:
• AST and ALT ≤ 2.5 x ULN or ≤ 5 x ULN in patients with liver metastases
• Total bilirubin ≤ 1.5 x ULN or ≤ 3.0 x ULN and primarily unconjugated if patient has a documented history of Gilbert's syndrome or genetic equivalent
• Laboratory measurements, coagulation function:
• International normalized ratio or prothrombin time (PT) ≤ 1.5 x ULN unless patient is receiving anticoagulation therapy, as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use for anticoagulants

You may not qualify if:

• Prior radiation therapy (or other nonsystemic therapy) within 2 weeks prior to enrollment
• Patient has not fully recovered (ie, ≤ Grade 1 at baseline) from AEs due to a previously administered treatment.
• Note: If a patient received major surgery, he or she must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
• Active CNS disease (patients with asymptomatic and stable, treated CNS lesions who have been off corticosteroids, radiation, or other CNS-directed therapy for at least 4 weeks are not considered active)
• History of hemolytic anemia, autoimmune thrombocytopenia, or Evans syndrome in the last 3 months
• Known inherited or acquired bleeding disorders
• Prior treatment with CD47 or SIRPα-targeting agents
• Prior anticancer therapy including, but not limited to, chemotherapy, immunotherapy, or investigational agents within 4 weeks prior to magrolimab treatment
• Life expectancy of less than 3 months and/or rapidly progressing disease (eg, tumor bleeding, uncontrolled tumor pain) in the opinion of the treating investigator
• Diagnosis of immunodeficiency or receipt of systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of study therapy. Corticosteroid use as a premedication for biopsy, allergic reactions or for prophylactic management of AEs related to the chemotherapies specified in the protocol is allowed. The use of physiologic doses of corticosteroids may be approved with approval by the sponsor.
• Active autoimmune disease that has required systemic treatment in the past 2 years (ie, use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
• Prior allogeneic tissue/solid organ transplant
• Current participation in another interventional clinical study
• History of previous malignancy other than malignancy treated with curative intent and with no evidence of active disease ≥ 2 years before the first dose of the study drugs and of low potential risk for recurrence. Patients with the following diagnoses represents an exception and may enroll:
• Non-melanoma skin cancers with no current evidence of disease

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• Gilead Sciences: collaborator

Study Sites (1)

M D Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• M D Anderson Cancer Center

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck

Interventions

pembrolizumab; magrolimab; Cetuximab; Docetaxel

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Results Point of Contact

• Title: Renata Ferrarotto, MD
• Organization: The University of Texas MD Anderson Cancer Center

rferrarotto@mdanderson.org

(713) 745-6774

Study Officials

• Renata Ferrarotto, M D

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 14, 2023
• First Posted: September 21, 2023
• Study Start: November 28, 2023
• Primary Completion: August 26, 2024
• Study Completion: August 26, 2024
• Last Updated: October 22, 2025
• Results First Posted: October 22, 2025

Record last verified: 2025-10

Locations

US (1)