AzTrials
AzTrials

Head NeckPhase 2NCT06046482

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

A Phase 2 study testing Pembrolizumab, Magrolimab and cetuximab in people with Head Neck and Squamous Cell Carcinoma of Head and Neck, run by M.D. Anderson Cancer Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Pembrolizumab, Magrolimab and cetuximab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4 participants
Where
1 siteUnited States
Study dates
28 Nov 2023to 26 Aug 2024
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • All patients must meet all of the following inclusion criteria to be eligible for participation in this study:
  • 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
Show all 31Show fewer
  • Laboratory measurements, blood counts:
  • Hemoglobin ≥ 9 g/dL within 24 hours prior to initial dose of study treatment. Red blood cell transfusions are permitted to meet the hemoglobin inclusion criteria, within limits set per exclusion criterion 6.
  • 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
  • Activated partial thromboplastin time or PTT ≤ 1.5 x ULN unless patient is receiving anticoagulation therapy, as long as PT or PTT is within therapeutic range of intended use for anticoagulants
  • Female patients with reproductive potential must practice two effective contraceptive measures for the duration of study drug therapy and for at least 6 months after completion of study therapy. The two birth control methods can be either two barrier methods or a barrier method plus a hormonal method to prevent pregnancy. The following are considered adequate barrier methods of contraception: diaphragm, condom, copper intrauterine device, sponge, or spermicide. Appropriate hormonal contraceptives will include any registered and marketed contraceptive agent that contains an estrogen and/or a progestational agent (including oral, subcutaneous, intrauterine, or intramuscular agents).
  • Male patients who are sexually active with women with reproductive potential must agree to use contraception for the duration of treatment and for at least 6 months after completion of study therapy.
  • Measurable disease according to RECIST, version 1.1
  • Patients must be willing to provide baseline tumor tissue from a core or excisional biopsy (fine needle aspirate is not adequate). A newly obtained biopsy (within 90 days prior to study treatment start) is strongly preferred, but an archival sample is acceptable.
  • Absence of active auto-immune disease or any other contra-indication to pembrolizumab, cetuximab, docetaxel or magrolimab
  • Cohort A:
  • In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Cohort A must fulfill the following cohort-specific inclusion criteria:
  • PD-L1 CPS must be ≥ 1
  • Patients should not have had prior systemic therapy administered in the recurrent or metastatic setting. Systemic therapy that was completed more than 3 months prior to signing consent if given as part of multimodal treatment for locally advanced disease is allowed.
  • Patients could have received anti-PD1 or anti-PD-L1 in the neoadjuvant or adjuvant setting as part of a clinical trial, as long as the patient has not progressed during it and there has been at least a 6 months disease-free interval since last administration of anti-PD1 or anti-PD-L1 in the curative intent setting.
  • Cohort B:
  • In addition to meeting the inclusion criteria for all patients, patients who are enrolled into Cohort B must fulfill the following cohort-specific inclusion criterion:
  • 17) Patients must have received at least 1 and no more than 2 lines of prior systemic anticancer therapy in the recurrent/metastatic setting not including docetaxel but including anti-PD1. Patients must have progressed on anti-PD1 (radiographically or clinically) or developed intolerable adverse events attributed to anti-PD1 that lead to treatment discontinuation and eventual disease progression. Patients with contra-indications to anti-PD1 are also eligible.

Who cannot join

  • Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
  • 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: Patients with ≤ Grade 2 neuropathy, alopecia, or laboratory values in inclusion criteria 5 through 8 are exceptions to this criterion and may qualify for the study.
  • 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)
Show all 27Show fewer
  • Red blood cell transfusion dependence, defined as requiring more than 2 units of packed RBC transfusions during the 4-week period prior to screening. Red blood cell transfusions are permitted during the screening period and prior to enrollment to meet the hemoglobin inclusion criterion.
  • 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
  • Melanoma in situ with no current evidence of disease
  • Localized cancer of the prostate with prostate-specific antigen of <1 ng/mL
  • Treated or localized well-differentiated thyroid cancer
  • Treated cervical carcinoma in situ
  • Treated ductal/lobular carcinoma in situ of the breast
  • Evidence of uncontrolled, active infection, requiring systemic anti-bacterial, anti-viral or anti-fungal therapy ≤ 10 days prior to administration of investigational product. Patients with known hepatitis B, hepatitis C (HCV), or HIV infection could go on study provided the viral load is undetectable at Screening.
  • Significant disease or medical conditions, as assessed by the investigator and sponsor, that would substantially increase the risk-benefit ratio of participating in the study. This includes, but is not limited to, acute myocardial infarction within the last 6 months, unstable angina, uncontrolled diabetes mellitus, significant active infections, and congestive heart failure New York Heart Association Class III-IV
  • Female subjects who are pregnant or breast-feeding
  • Known hypersensitivity to any of the study drugs, the metabolites, or formulation excipient

Trial locations and contacts

1 site in 1 country.

United States1 site

  • M D Anderson Cancer Center

    Houston, Texas, 77030

Other trials in United States

About this study

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.

Read the detailed description

Primary Objectives:

-Objective response rate (ORR) per RECIST v1.1

Secondary Objectives:

  • Adverse events rates per CTCAE V5.0 (appendix)
  • Duration of response (DOR)
  • Progression free survival (PFS) per RECIST v1.1
  • Overall survival (OS) per RECIST v1.1

Exploratory Objectives:

-Assessment of blood and tissue-based biomarkers predictive of response to therapy

Being tested
Pembrolizumab, Magrolimab, cetuximab, Docetaxel
Medical subject headings
Squamous Cell Carcinoma of Head and Neck

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PembrolizumabDrug

    Also called KEYTRUDA®

    Given by IV (vein)

  • MagrolimabDrug

    Given by IV (vein)

  • cetuximabDrug

    Also called ERBITUX

    Given by IV (vein)

  • DocetaxelDrug

    Given by IV (vein)

Study groups in NCT06046482
Study groupRoleWhat they receive
Cohort AExperimentalParticipants will receive magrolimab and cetuximab along with pembrolizumab.
Receives: Drug: Pembrolizumab; Drug: Magrolimab; Drug: cetuximab
Cohort BExperimentalParticipants will receive magrolimab and cetuximab along with docetaxel.
Receives: Drug: Magrolimab; Drug: cetuximab; Drug: Docetaxel

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: 140 days

Secondary outcomes (3)

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

    Adverse events (AEs) are categorized as follows: Treatment-Emergent Adverse Events (TEAEs), which refer to any AEs that arise or worsen in severity after the initiation of treatment with the study product; and Treatment-Related Adverse Events (TRAEs), defined as TEAEs that are considered possibly, probably, or definitely related to the treatment. Adverse Events were graded 1 to 5 via CTAE 5.0 guidelines. All AEs, whether serious or non-serious, will be captured from the time of the first administration of the investigational agent until 30 days following the last dose of study drug or until the initiation of alternative anticancer therapy

    Measured: 145 days

  2. Duration of Response (DOR)

    Time (the duration of overall response is measured from the time measurement criteria are met for CR or PR (whichever is first recorded) until the first date that recurrent or progressive disease is objectively documented.

    Measured: 2 weeks and 1 day

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

    Progression free survival (PFS) per RECIST v1.1. Progression is defined using Response Evaluation Criteria in Solid Tumors Criteria (RECIST v1.1) as a 20% increase in the sum of the longest diamester of target lesions, a measurable increase in a non-target lesion, or the appearance of new lesions

    Measured: 4 months and 4 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Sep 2023
  2. Study start28 Nov 2023
  3. Primary completion26 Aug 2024
  4. Study completion26 Aug 2024

Why it stopped: Slow Accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
4 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06046482
Sponsor's protocol ID
2022-0903
Other IDs
NCI-2023-07199
Status last verified
Oct 2025
First submitted
14 Sep 2023
Last updated
22 Oct 2025
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Pembrolizumab, Magrolimab and cetuximab in people with Head Neck and Squamous Cell Carcinoma of Head and Neck, run by M.D. Anderson Cancer Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 22 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 22 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: 140 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06046482.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2025.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in