Brief Title: A Dose Escalation and Cohort Expansion Study of NKTR-214 in Combination With Nivolumab and Other Anti-Cancer Therapies in Patients With Select Advanced Solid Tumors ( PIVOT-02 )

PRIMARY OUTCOMES

Primary Outcome 1 - Measure: Part 1 Dose Escalation: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window

Primary Outcome 1 - Timeframe: Includes DLTs that occurred within the DLT window of at least 21 days after the first dose of study treatment (28 days for every 2 weeks dosing; 21 days for every 3 weeks dosing). Patients were counted only once under each preferred term.

Primary Outcome 2 - Measure: Part 3 Schedule Finding: Incidence of Dose-limiting Toxicity (DLT) During the DLT Evaluation Window

Primary Outcome 2 - Timeframe: Dose-limiting toxicities (DLTs) were assessed during a 3-week (21-day) DLT evaluation period beginning with the first dose of ipilimumab.

Primary Outcome 3 - Measure: Part 2 and Part 4: Objective Response Rate (ORR) Per RECIST 1.1 at Recommended Phase 2 Dose (RP2D)

Primary Outcome 3 - Timeframe: Tumor assessment at Screening then every 8 weeks (± 7 days) from Cycle 1 Day 1 and end of treatment (unless scan done within 4 weeks) up to approximately 27 months.

CONDITION

• Melanoma
• Renal Cell Carcinoma
• Non Small Cell Lung Cancer
• Urothelial Carcinoma
• Triple Negative Breast Cancer
• HR+/HER2- Breast Cancer
• Gastric Cancer

ELIGIBILITY

INCLUSION CRITERIA - For Parts 1-4:
* Histologically confirmed diagnosis of a locally advanced (not amenable to curative therapy such as surgical resection) or metastatic solid tumors

- * Life expectancy > 12 weeks

- * Patients must not have received prior interleukin-2 (IL-2) therapy

- * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1

- * Measurable disease per RECIST 1.1

- * Patients with stable brain metastases under certain criteria

- * Fresh and archival tumor tissue available Tumor specific inclusion criteria may apply.
EXCLUSION CRITERIA - For Parts 1-4:
* Use of an investigational agent or an investigational device within 28 days before administration of first dose of NKTR--214

- * Females who are pregnant or breastfeeding

- * Participants who have an active autoimmune disease requiring systemic treatment within the past 3 months or have a documented history of clinically severe autoimmune disease that requires systemic steroids or immunosuppressive agents

- * History of organ transplant that requires use of immune suppressive agents

- * Active malignancy not related to the current diagnosed malignancy

- * Evidence of clinically significant interstitial lung disease or active, noninfectious pneumonitis

- * Participants who have had < 28 days since the last chemotherapy, biological therapy, or < 14 days from approved tyrosine kinase inhibitor (TKI) therapy, or systemic or inhaled steroid therapy at doses greater than 10mg of prednisone Tumor specific exclusion criteria may apply.
Other protocol defined inclusion/exclusion criteria may apply

Gender: All

Minimum Age: 18 Years

Maximum Age: N/A

Healthy Volunteers: No

OFFICIAL INFORMATION

Name: Study Director

Role: Study Director

Affiliation: Nektar Therapeutics

Overall Contact

Name: N/A

Phone: N/A

Email: N/A

LOCATION