A PHASE 2 STUDY OF ALX148 IN COMBINATION WITH PEMBROLIZUMAB IN PATIENTS WITH ADVANCED HEAD AND NECK SQUAMOUS CELL CARCINOMA (ASPEN-03)

Conditions

metastatic or unresectable, recurrent HNSCC

Brief summary

Objective response rate of ALX148 plus pembrolizumab (ORR; CR or PR using the Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).

Detailed description

Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP), Progression-free survival (PFS), and overall survival (OS), Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0), timing, seriousness, and relationship to study therapy, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v. 5.0) and timing, Pharmacokinetic parameters of ALX148 such as Cmax, Tmax, AUC, CL, and t1/2 as data permit, Immunogenicity; Human serum ADA (i.e., anti-ALX148 antibody) samples will be analyzed for the presence or absence of anti-ALX148 antibodies

Related papers

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Interventions

DRUGevorpacept

DRUGKEYTRUDA 25 mg/mL concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Objective response rate of ALX148 plus pembrolizumab (ORR; CR or PR using the Response Evaluation Criteria in Solid Tumors [RECIST] version 1.1).	—

Secondary

Measure	Time frame
Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP), Progression-free survival (PFS), and overall survival (OS), Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0), timing, seriousness, and relationship to study therapy, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v. 5.0) and timing, Pharmacokinetic parameters of ALX148 such as Cmax, Tmax, AUC, CL, and t1/2 as data permit, Immunogenicity; Human serum ADA (i.e., anti-ALX148 antibody) samples will be analyzed for the presence or absence of anti-ALX148 antibodies	—

Measure

Time frame

Disease control rate (DCR), duration of response (DOR), time to tumor progression (TTP), Progression-free survival (PFS), and overall survival (OS), Adverse Events as characterized by type, frequency, severity (as graded by National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE v. 5.0), timing, seriousness, and relationship to study therapy, Laboratory abnormalities as characterized by type, frequency, severity (as graded by NCI CTCAE v. 5.0) and timing, Pharmacokinetic parameters of ALX148 such as Cmax, Tmax, AUC, CL, and t1/2 as data permit, Immunogenicity; Human serum ADA (i.e., anti-ALX148 antibody) samples will be analyzed for the presence or absence of anti-ALX148 antibodies

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Countries

Belgium, Netherlands, Spain

Outcome results

None listed