Bempegaldesleukin and Pembrolizumab With or Without Chemotherapy in Locally Advanced or Metastatic Solid Tumors
This study is to assess the safety and tolerability, and to assess the preliminary clinical benefit of NKTR-214 when combined with pembrolizumab (KEYTRUDA®) with or without chemotherapy. The study is comprised of two groups; dose optimization and dose expansion cohorts. Dose Optimization included first-line and second-line advanced or metastatic solid tumors including non-small cell lung cancer (NSCLC) The dose expansion cohort will include first-line NSCLC patients.
Ask AI to explain this studyKey things to know
This describes the study’s primary purpose.
Plus 8 other study approaches.
These are broad labels—not an eligibility decision.
Checked against the public recordLast updated Mar 10, 2023 · Source: ClinicalTrials.gov
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Interventional
Locations may change over time.
Study sponsor
What this study is about
- Purpose
- Treatment
- Study type
- Interventional
- Phase
- Phase 1 / Phase 2
- Sponsor
- Nektar Therapeutics
- Interventions being studied
- Drug: NKTR-214; Drug: Pembrolizumab; Drug: NKTR-214; Drug: NKTR-214; Drug: Cisplatin; Drug: Carboplatin; Drug: Nab paclitaxel; Drug: Paclitaxel; Drug: Pemetrexed; Drug: Atezolizumab
How this study is categorized
These labels come from structured fields and exact terms in the public record.
Who may be able to participate
The sponsor separates these requirements into two groups. You do not need to interpret them alone—use them to guide a conversation with the study team.
- Dose Optimization and Dose Expansion Inclusion Criteria:
- Willing and able to provide written informed consent.
- Male or female patients, age 18 years or older at the time of signing the informed consent form (ICF).
- Life expectancy \> 12 weeks from the time of enrollment as determined by the Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Oxygen saturation ≥ 92% on room air for all indications.
- Measurable disease per RECIST 1.1.
- Patients with brain metastases are eligible if certain criteria are met.
- Availability of fresh or archival tumor tissue
- Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment Dose Expansion Inclusion Criteria (Non-Small Cell Lung Cancer):
- Histologically confirmed diagnosis of stage IV NSCLC.
- Patients must have a minimum of 6 months of response to any nonpalliative cancer-directed treatment.
- Patients with actionable mutations with approved targeted therapy in NSCLC are excluded. Testing for mutations should be performed per standard of care.
- Must not have received anti-cancer therapy for treatment of metastatic lung cancer
- Must not have received prior immunotherapy
- Use of an investigational agent or an investigational device within 28 days before administration of first dose of study drug(s).
- Females who are pregnant or breastfeeding.
- Patients who have an active autoimmune disease
- History of allergy or hypersensitivity to study drug components
- Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis.
- Prior surgery or radiotherapy within 14 days of therapy.
- For Dose Optimization Cohort 1 only: Chemotherapy or biological therapy within 28 days of enrollment. Targeted therapy (e.g., tyrosine kinase inhibitors) within 14 days of enrollment. Patients with ongoing AEs related to prior cancer therapies will be excluded.
- Participant's inability to adhere to or tolerate protocol or study procedures NOTE: Other protocol defined Inclusion/
Important: This is the sponsor’s public criteria, not a determination of eligibility. The study team must review your individual situation.
U.S. locations
- Highlands Oncology Group, PA - North HillsFayetteville, Arkansas
- California Pacific Medical CenterSan Francisco, California
- University of Colorado Anschutz Medical CampusAurora, Colorado
- Augusta University - Augusta University Medical CenterAugusta, Georgia
- Ochsner Medical CenterNew Orleans, Louisiana
- Henry Ford HospitalDetroit, Michigan
- Park Nicollet - Frauenshuh Cancer CenterSaint Louis Park, Minnesota
- Washington University School of Medicine in St. LouisSt Louis, Missouri
- St. Vincent Frontier Cancer CenterBillings, Montana
- University of Nebraska Medical CenterOmaha, Nebraska
- Comprehensive Cancer Centers of Nevada (CCCN) - Central ValleyLas Vegas, Nevada
- Rutgers Cancer Institute of New JerseyNew Brunswick, New Jersey
Source and freshness
Processed from ClinicalTrials.gov. Last public update: Mar 10, 2023. Always confirm current availability with the study team.