Symptoms and General Pathology

All Conditions

Neoplasms

Recurrence

Carcinoma

Carcinoma, Squamous Cell

Head and Neck Neoplasms

Disease Attributes

Antineoplastic Agents

All Drugs and Chemicals

Anti-Allergic Agents

Anti-Inflammatory Agents

Dermatologic Agents

Pembrolizumab

Mometasone Furoate

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Bempegaldesleukin plus pembrolizumab every 3 weeks (q3w) for up to 35 cycles (approximately 2 years).

Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).

Bempegaldesleukin

Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.

Study Director

This is a multicenter, randomized, open-label, Phase 2/3 study that will evaluate the efficacy and safety of bempegaldesleukin (BEMPEG; NKTR-214) combined with pembrolizumab compared with pembrolizumab monotherapy in patients with recurrent or metastatic HNSCC with positive PD-L1 expression (CPS ≥ 1).

BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

A Phase 2/3, Randomized, Open-label Study to Compare Bempegaldesleukin Combined With Pembrolizumab Versus Pembrolizumab Alone in First-Line Treatment of Patients With Metastatic or Recurrent Head and Neck Squamous-Cell Carcinoma With PD-L1 Expressing Tumors (PROPEL-36)

To compare the objective response rate (ORR) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.

To compare progression-free survival (PFS) of bempegaldesleukin plus pembrolizumab versus pembrolizumab monotherapy.

The 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.

To 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.

Compare the overall safety and tolerability based on assessments of treatment-emergent adverse events and serious adverse events

SFJ Pharmaceuticals, Inc.

Merck Sharp & Dohme LLC

Nektar Therapeutics

There were no SAEs, no mortalities. In total, one Grade 1 AE of cough was reported.

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.

BEMPEG + Pembrolizumab

Pembrolizumab monotherapy q3w for up to 35 cycles (approximately 2 years).

Pembrolizumab: Pembrolizumab (anti-PD-1) will be dosed as per the pharmacy manual.

Pembrolizumab Monotherapy

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Austria

Greece

United States

Italy

Region of Enrollment

Following the Sponsor's decision to end the trial, treatment was discontinued after one patient received 2 cycles of BEMPEG + Pembrolizumab

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.

Spots Global Cancer Trial Database for BEMPEG With Pembrolizumab vs Pembrolizumab Alone in Patients With Metastatic or Recurrent HNSCC (PROPEL-36)

Trial Identification

Conditions

Interventions

Study Description

Keywords

Eligibility

Locations

Contact Details

Useful links and downloads for this trial