Evorpacept (ALX148) in Combination With Pembrolizumab and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04)
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ClinicalTrials.gov Identifier: NCT04675333 |
Recruitment Status :
Recruiting
First Posted : December 19, 2020
Last Update Posted : March 22, 2024
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Head and Neck Cancer Head and Neck Squamous Cell Carcinoma | Drug: evorpacept Drug: pembrolizumab Drug: Cisplatin/Carboplatin; 5FU | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 168 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 and Chemotherapy in Patients With Advanced Head and Neck Squamous Cell Carcinoma (ASPEN-04) |
Actual Study Start Date : | May 10, 2021 |
Estimated Primary Completion Date : | December 31, 2024 |
Estimated Study Completion Date : | December 31, 2025 |
Arm | Intervention/treatment |
---|---|
Experimental: evorpacept (ALX148) + pembrolizumab + Chemotherapy
evorpacept (ALX148) 45 mg/kg IV, pembrolizumab 200 mg IV, and chemotherapy given every 3 weeks.
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Drug: evorpacept
IV Q3W
Other Name: ALX148 Drug: pembrolizumab IV Q3W
Other Name: KEYTRUDA® Drug: Cisplatin/Carboplatin; 5FU IV Q3W
Other Name: Platinol/Paraplatin; Adrucil |
Active Comparator: pembrolizumab + Chemotherapy
pembrolizumab 200 mg IV and chemotherapy given every 3 weeks.
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Drug: pembrolizumab
IV Q3W
Other Name: KEYTRUDA® Drug: Cisplatin/Carboplatin; 5FU IV Q3W
Other Name: Platinol/Paraplatin; Adrucil |
- 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 ]
- 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 ]
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Previously untreated metastatic or unresectable, recurrent head and neck squamous cell carcinoma.
- 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 current pneumonitis.
- Prior treatment with any anti-CD47 or anti-SIRPα agent.
- Prior treatment with anti-PD-1 or PD-L1.
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): NCT04675333
Contact: Harry Liu, MD, MPH, MBA | +1 650.502.4697 | info@alxoncology.com | |
Contact: Richard J Morishige, MS | 1 650.666.0492 | info@alxoncology.com |
United States, California | |
Hoag Hospital | Recruiting |
Irvine, California, United States, 92618 | |
University of California San Diego | Recruiting |
La Jolla, California, United States, 92037 | |
United States, Florida | |
Sylvester Comprehensive Cancer Center | Recruiting |
Miami, Florida, United States, 33136 | |
United States, Illinois | |
Rush University Medical Center | Recruiting |
Chicago, Illinois, United States, 60612 | |
United States, Kentucky | |
University of Louisville | Recruiting |
Louisville, Kentucky, United States, 40202 | |
United States, Maryland | |
University of Maryland Medical System | Recruiting |
Baltimore, Maryland, United States, 21201 | |
United States, Tennessee | |
Vanderbilt - Ingram Cancer Center | Recruiting |
Nashville, Tennessee, United States, 37232 | |
Australia, South Australia | |
Ashford Cancer Centre | Recruiting |
Adelaide, South Australia, Australia, 5037 | |
Belgium | |
Cliniques Universitaires Saint-Luc | Recruiting |
Bruxelles, Belgium | |
Spain | |
Hospital Universitari Dexeus | Recruiting |
Barcelona, Spain, 08028 | |
Hospital Universitario La Paz | Recruiting |
Madrid, Spain |
Responsible Party: | ALX Oncology Inc. |
ClinicalTrials.gov Identifier: | NCT04675333 |
Other Study ID Numbers: |
AT148004 KEYNOTE-B88 ( Other Identifier: Merck Sharp & Dohme LLC ) MK-3475-B88 ( Other Identifier: Merck Sharp & Dohme LLC ) 2020-004662-19 ( 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 |
ALX148 CD47 SIRPα |
HNSCC pembrolizumab evorpacept |
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 Carboplatin Pembrolizumab Antineoplastic Agents Antineoplastic Agents, Immunological Immune Checkpoint Inhibitors Molecular Mechanisms of Pharmacological Action |