IRB #

IRB00011638

Title

A Phase 2 Proof-of-Concept Study of the Combination of ACP-196 and Pembrolizumab in Subjects with Advanced Head and Neck Squamous Cell Carcinoma

Principal Investigator

Matthew Taylor

Study Purpose

To determine the safety and tolerability of ACP-196 (study drug) in combination with keytruda in patients with advanced head and neck squamous cell carcinoma.

Medical Condition(s)

Head and neck squamous cell carcinoma (HNSCC)

Eligibility Criteria

1. Male or female age 18 or older
2. Confirmed diagnosis of recurrent, metastatic, or unresectable HNSCC
3. Disease progression after either a) platinum-based chemotherapy for metastatic disease or b) recurrence within 6 months of platinum-based neoadjuvant or adjuvant therapy
4. Ability to swallow capsules
5. Other criteria apply

Age Range

18 - 100

Healthy Volunteers Needed

No

Duration of Participation

Treatment can continue for up to 52 weeks for subjects who are tolerating therapy
and have not developed progressive disease. After discontinuing study therapy, subjects will be contacted by phone about every 3 months.

Minors Included

No

Contact

Knight Clinical Trials Information Line
503-494-1080

Sponsor

Acerta Pharma BV

Recruitment End

06/30/2021

Compensation Provided

No


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