Trial Outcomes & Findings for IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma (NCT NCT03795610)

Last Updated: 2025-07-25

Results Overview

To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

7 weeks

Results posted on

2025-07-25

Participant milestones
Measure	Arm A: IPI-549 40 mg PO Qdaily Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days IPI-549: 40mg by mouth (PO) every day (QD) for at least 14 days
Overall Study STARTED	16
Overall Study COMPLETED	10
Overall Study NOT COMPLETED	6

Reasons for withdrawal
Measure	Arm A: IPI-549 40 mg PO Qdaily Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days IPI-549: 40mg by mouth (PO) every day (QD) for at least 14 days
Overall Study Screen Failure (Did not meet inclusion/exclusion)	4
Overall Study Withdrawal by Subject	1
Overall Study Screen Failure (Unknown)	1

IPI-549 in Patients With Locally Advanced HPV+ and HPV- Head and Neck Squamous Cell Carcinoma

Baseline characteristics by cohort
Measure	Arm A: IPI-549 40 mg PO Qdaily n=10 Participants Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days IPI-549: 40mg by mouth (PO) every day (QD) for at least 14 days
Age, Categorical <=18 years	0 Participants n=99 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=99 Participants
Age, Categorical >=65 years	3 Participants n=99 Participants
Age, Continuous	56.2 Years STANDARD_DEVIATION 13.29 • n=99 Participants
Sex: Female, Male Female	3 Participants n=99 Participants
Sex: Female, Male Male	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=99 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=99 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=99 Participants
Race (NIH/OMB) Asian	1 Participants n=99 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=99 Participants
Race (NIH/OMB) Black or African American	1 Participants n=99 Participants
Race (NIH/OMB) White	5 Participants n=99 Participants
Race (NIH/OMB) More than one race	1 Participants n=99 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=99 Participants
Cancer Type Nasal cavity	1 Participants n=99 Participants
Cancer Type Oral cavity	4 Participants n=99 Participants
Cancer Type Oropharynx	5 Participants n=99 Participants

Timeframe: 7 weeks

To determine safety and tolerability of IPI-549 in patients with locally advanced HNSCC.

Outcome measures
Measure	Arm A: IPI-549 40 mg PO Qdaily n=10 Participants Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days IPI-549: 40mg by mouth (PO) every day (QD) for at least 14 days
Participants Experiencing Adverse Events	10 Participants

Serious events: 2 serious events

Other events: 9 other events

Deaths: 0 deaths

Serious adverse events
Measure	Arm A: IPI-549 40 mg PO Qdaily n=10 participants at risk Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days IPI-549: 40mg by mouth (PO) every day (QD) for at least 14 days
Infections and infestations Sepsis	10.0% 1/10 • Number of events 1 • 7 weeks
Gastrointestinal disorders Oral hemorrhage	10.0% 1/10 • Number of events 1 • 7 weeks

Other adverse events
Measure	Arm A: IPI-549 40 mg PO Qdaily n=10 participants at risk Patients enrolled in Arm A will receive IPI-549 40 mg by mouth daily for at least 14 days IPI-549: 40mg by mouth (PO) every day (QD) for at least 14 days
Gastrointestinal disorders Gastrointestinal disorders	80.0% 8/10 • Number of events 14 • 7 weeks
General disorders General disorders and administration site conditions	40.0% 4/10 • Number of events 4 • 7 weeks
Immune system disorders Immune system disorders	10.0% 1/10 • Number of events 1 • 7 weeks
Investigations Investigations	10.0% 1/10 • Number of events 2 • 7 weeks
Nervous system disorders Nervous system disorders	30.0% 3/10 • Number of events 5 • 7 weeks
Psychiatric disorders Psychiatric disorders	10.0% 1/10 • Number of events 1 • 7 weeks
Renal and urinary disorders Renal and urinary disorders	10.0% 1/10 • Number of events 1 • 7 weeks
Respiratory, thoracic and mediastinal disorders Respiratory, thoracic and mediastinal disorders	10.0% 1/10 • Number of events 1 • 7 weeks
Skin and subcutaneous tissue disorders Skin and subcutaneous tissue disorders	10.0% 1/10 • Number of events 1 • 7 weeks
Vascular disorders Vascular disorders	10.0% 1/10 • Number of events 1 • 7 weeks

University of California, San Diego

Phone: (858) 822-6100