Trial Outcomes & Findings for BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36) (NCT NCT04969861)
NCT ID: NCT04969861
Last Updated: 2023-01-12
Results Overview
TERMINATED
PHASE2/PHASE3
1 participants
Approximately 2 years
2023-01-12
Participant Flow
Participant milestones
| Measure |
BEMPEG + Pembrolizumab
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
Bempegaldesleukin: Specified dose on specified days
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
Pembrolizumab Monotherapy
Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
|
Overall Study
COMPLETED
|
0
|
0
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
| Measure |
BEMPEG + Pembrolizumab
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
Bempegaldesleukin: Specified dose on specified days
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
Pembrolizumab Monotherapy
Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
|---|---|---|
|
Overall Study
Study was terminated in consonance with discontinuation of bempegaldesleukin program.
|
1
|
0
|
Baseline Characteristics
BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)
Baseline characteristics by cohort
| Measure |
BEMPEG + Pembrolizumab
n=1 Participants
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
Bempegaldesleukin: Specified dose on specified days
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
Pembrolizumab Monotherapy
Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
Total
n=1 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Age, Continuous
|
69 years
n=99 Participants
|
—
|
69 years
n=206 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=99 Participants
|
—
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
—
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Austria
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
|
Region of Enrollment
Greece
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
|
Region of Enrollment
United States
|
1 participants
n=99 Participants
|
—
|
1 participants
n=206 Participants
|
|
Region of Enrollment
Italy
|
0 participants
n=99 Participants
|
—
|
0 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Approximately 2 yearsPopulation: Nektar and BMS Study PIVOT-IO-001 did not meet its primary EP of demonstrating an efficacy advantage from addition of BEMPEG to nivolumab in patients with previously untreated inoperable or metastatic melanoma. PIVOT-09 (RCC) and PIVOT-10 (uroth C) studies also reported negative topline results. Based on these 3 large negative studies, Nektar and SFJ in consultation with the study IDMC made the decision to discontinue this trial. At termination, 1 patient was enrolled and treated for 2 cycles.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: Approximately 2 yearsTo compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsTo compare progression-free survival (PFS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsThe time from baseline to a ≥ 10-point decrease with confirmation by the subsequent visit of a ≥ 10-point deterioration from baseline in: • Global health status/quality of life assessment based on the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Core 30 (QLQ-C30). The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients. All scale scores are linearly converted to range from 0 to 100. A higher total score indicates a better level of functioning. • Pain and Swallowing based on respective multi-item scales of EORTC QLQ head and neck cancer specific module (EORTC QLQ-H\&N35). EORTC QLQ-H\&N35 consists of 7 multi-item scales that assess pain, swallowing, senses, speech, social eating, social contact and sexuality. All scale scores are linearly converted to range from 0 to 100. A higher total score indicates increased severity of symptoms.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Approximately 2 yearsTo compare mean change from baseline in global health status/quality of life scale of EORTC QLQ-C30. The EORTC QLQ-C30 is composed of multi-item scales and single item measures. These include 5 functional scales (physical, role, emotional, cognitive, and social), 3 symptom scales (fatigue, nausea/vomiting, and pain), a global health status/HRQoL scale, and 6 single items (dyspnea, insomnia, appetite loss, constipation, diarrhea, and financial difficulties). Each of the multi-item scales includes a different set of items - no item occurs in more than one scale. All scale scores are linearly converted to range from 0 to 100. A higher total score indicates a better level of functioning.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Screening baseline through end of study, approximately 2 yearsCompare the overall safety and tolerability based on assessments of treatment-emergent adverse events and serious adverse events
Outcome measures
Outcome data not reported
Adverse Events
BEMPEG + Pembrolizumab
Pembrolizumab Monotherapy
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
BEMPEG + Pembrolizumab
n=1 participants at risk
Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).
Bempegaldesleukin: Specified dose on specified days
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
Pembrolizumab Monotherapy
Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).
Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
100.0%
1/1 • Number of events 1 • 1 month
There were no SAEs, no mortalities. In total, one Grade 1 AE of cough was reported.
|
—
0/0 • 1 month
There were no SAEs, no mortalities. In total, one Grade 1 AE of cough was reported.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee There are restrictions to the PI's rights to discuss or publish trial results.
- Publication restrictions are in place
Restriction type: OTHER