Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma
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ClinicalTrials.gov Identifier: NCT06046482 |
Recruitment Status :
Suspended
(PI Request)
First Posted : September 21, 2023
Last Update Posted : April 12, 2024
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Tracking Information | |||||
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First Submitted Date ICMJE | September 14, 2023 | ||||
First Posted Date ICMJE | September 21, 2023 | ||||
Last Update Posted Date | April 12, 2024 | ||||
Actual Study Start Date ICMJE | November 28, 2023 | ||||
Estimated Primary Completion Date | November 30, 2027 (Final data collection date for primary outcome measure) | ||||
Current Primary Outcome Measures ICMJE |
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0 [ Time Frame: through study completion; an average of 1 year ] | ||||
Original Primary Outcome Measures ICMJE | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures ICMJE | Not Provided | ||||
Original Secondary Outcome Measures ICMJE | Not Provided | ||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||
Descriptive Information | |||||
Brief Title ICMJE | Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma | ||||
Official Title ICMJE | Phase II Trial of Magrolimab and Cetuximab With Pembrolizumab or Docetaxel for Recurrent/Metastatic Head Neck Squamous Cell Carcinoma | ||||
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. | ||||
Detailed Description | Primary Objectives: -Objective response rate (ORR) per RECIST v1.1 Secondary Objectives:
Exploratory Objectives: -Assessment of blood and tissue-based biomarkers predictive of response to therapy |
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Study Type ICMJE | Interventional | ||||
Study Phase ICMJE | Phase 2 | ||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment |
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Condition ICMJE |
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Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||
Recruitment Status ICMJE | Suspended | ||||
Estimated Enrollment ICMJE |
57 | ||||
Original Estimated Enrollment ICMJE | Same as current | ||||
Estimated Study Completion Date ICMJE | November 30, 2029 | ||||
Estimated Primary Completion Date | November 30, 2027 (Final data collection date for primary outcome measure) | ||||
Eligibility Criteria ICMJE | Inclusion Criteria: All patients must meet all of the following inclusion criteria to be eligible for participation in this study:
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. Exclusion Criteria: Patients who meet any of the following exclusion criteria are not eligible to be enrolled in this study:
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Sex/Gender ICMJE |
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Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||
Accepts Healthy Volunteers ICMJE | No | ||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
Listed Location Countries ICMJE | United States | ||||
Removed Location Countries | |||||
Administrative Information | |||||
NCT Number ICMJE | NCT06046482 | ||||
Other Study ID Numbers ICMJE | 2022-0903 NCI-2023-07199 ( Other Identifier: NCI-CTRP Clinical Trials Registry ) |
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Has Data Monitoring Committee | Yes | ||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE | Not Provided | ||||
Current Responsible Party | M.D. Anderson Cancer Center | ||||
Original Responsible Party | Same as current | ||||
Current Study Sponsor ICMJE | M.D. Anderson Cancer Center | ||||
Original Study Sponsor ICMJE | Same as current | ||||
Collaborators ICMJE | Gilead Sciences | ||||
Investigators ICMJE |
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PRS Account | M.D. Anderson Cancer Center | ||||
Verification Date | April 2024 | ||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |