Trial record 1 of 1 for:
ASPEN03
Evorpacept (ALX148) in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03)
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| ClinicalTrials.gov Identifier: NCT04675294 |
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Recruitment Status :
Recruiting
First Posted : December 19, 2020
Last Update Posted : March 22, 2024
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Sponsor:
ALX Oncology Inc.
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
ALX Oncology Inc.
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Brief Summary:
A Phase 2 Study of evorpacept (ALX148) in Combination With pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Head and Neck Cancer Head and Neck Squamous Cell Carcinoma | Drug: evorpacept Drug: pembrolizumab | Phase 2 |
This is a open-label, randomized phase 2 multi-center study of the anti-tumor efficacy of evorpacept (ALX148) + pembrolizumab and of pembrolizumab alone in patients with metastatic or unresectable, recurrent HNSCC that is PD-L1 positive (CPS ≥1 by an FDA-approved test) and who have not yet been treated for their advanced disease. The study comprises an initial safety lead-in cohort followed by a randomized portion.
| Study Type : | Interventional (Clinical Trial) |
| Estimated Enrollment : | 183 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | None (Open Label) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase 2 Study of ALX148 in Combination With Pembrolizumab in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-03) |
| Actual Study Start Date : | April 2, 2021 |
| Estimated Primary Completion Date : | December 31, 2024 |
| Estimated Study Completion Date : | December 31, 2025 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Head and neck squamous cell carcinoma
Drug Information
available for:
Pembrolizumab
| Arm | Intervention/treatment |
|---|---|
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Experimental: evorpacept (ALX148) + pembrolizumab
evorpacept (ALX148) 45 mg/kg IV and pembrolizumab 200 mg IV given every 3 weeks.
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Drug: evorpacept
IV Q3W
Other Name: ALX148 Drug: pembrolizumab IV Q3W
Other Name: KEYTRUDA® |
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Active Comparator: pembrolizumab
pembrolizumab 200 mg IV given every 3 weeks.
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Drug: pembrolizumab
IV Q3W
Other Name: KEYTRUDA® |
Primary Outcome Measures :
- Objective response rate per RECIST 1.1 [ Time Frame: Last randomized patient reaching at least 24 weeks of follow-up ]
- 12-month overall survival rate [ Time Frame: Last randomized patient reaching 12 months of follow-up ]
Secondary Outcome Measures :
- Duration of response [ Time Frame: Up to 36 months ]
- Progression-free survival [ Time Frame: Up to 36 months ]
- Overall survival [ Time Frame: Up to 36 months ]
- Adverse events [ Time Frame: Up to 36 months ]
Information from the National Library of Medicine
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Patients with metastatic or unresectable, recurrent head and neck squamous cell carcinoma (HNSCC) that is PD-L1 positive (CPS > 1) and who have not received prior systemic therapy for their advanced disease.
- Adequate bone marrow function.
- Adequate renal and liver function.
- Adequate ECOG performance status.
Exclusion Criteria:
- Patients with known symptomatic CNS metastases or leptomeningeal disease requiring steroids.
- History of (non-infectious) pneumonitis that required steroids or has current pneumonitis.
- Prior treatment with any anti-CD47 or anti-SIRPα agent.
- Prior treatment with anti-PD-1 or PD-L1.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04675294
Contacts
| Contact: Harry Liu, MD, MPH, MBA | 1 650.502.4697 | info@alxoncology.com |
Locations
Show 53 study locations
Sponsors and Collaborators
ALX Oncology Inc.
Merck Sharp & Dohme LLC
| Responsible Party: | ALX Oncology Inc. |
| ClinicalTrials.gov Identifier: | NCT04675294 |
| Other Study ID Numbers: |
AT148003 KEYNOTE-B87 ( Other Identifier: Merck Sharp & Dohme LLC ) MK-3475-B87 ( Other Identifier: Merck Sharp & Dohme LLC ) 2020-004093-21 ( EudraCT Number ) |
| First Posted: | December 19, 2020 Key Record Dates |
| Last Update Posted: | March 22, 2024 |
| Last Verified: | February 2024 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Keywords provided by ALX Oncology Inc.:
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ALX148 CD47 SIRPα |
HNSCC pembrolizumab evorpacept |
Additional relevant MeSH terms:
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Carcinoma Carcinoma, Squamous Cell Squamous Cell Carcinoma of Head and Neck Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplasms Neoplasms, Squamous Cell |
Head and Neck Neoplasms Neoplasms by Site Pembrolizumab Antineoplastic Agents, Immunological Antineoplastic Agents Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |