PIVOT-10: A Single-Arm Study of Bempegaldesleukin (NKTR-214) Plus Nivolumab in Cisplatin Ineligible Patients Who Have Locally Advanced or Metastatic Urothelial Cancer

• Sponsor: Nektar Therapeutics (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03785925
• Collaborator: Bristol-Myers Squibb (Industry)
• Enrollment: 192
• Locations: 70
• Arm: 1
• Actual Duration (Months): 38
• Patients Per Site: 2.7
• Patients Per Site Per Month: 0.1

Study Details

Study Description

Brief Summary

The main purpose of this study is to evaluate the anti-tumor activity of bempegaldesleukin (NKTR-214) in combination with nivolumab by assessing the objective response rate (ORR) in cisplatin ineligible, locally advanced or metastatic urothelial cancer patients.

Condition or Disease	Intervention/Treatment	Phase
Urinary Bladder Neoplasm; Neoplasm Metastasis	Biological: Bempegaldesleukin; Biological: Nivolumab	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 192 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Single-Arm Study of Bempegaldesleukin (NKTR-214) in Combination With Nivolumab in Cisplatin Ineligible, Locally Advanced or Metastatic Urothelial Cancer Patients
• Actual Study Start Date: Apr 29, 2019
• Actual Primary Completion Date: Feb 9, 2022
• Actual Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Combination of bempegaldesleukin (NKTR-214) + nivolumab Participants will receive bempegaldesleukin (NKTR-214) in combination with nivolumab.	Biological: Bempegaldesleukin; Specified dose on specified days; Other Names: NKTR-214 BMS-986321 ; Biological: Nivolumab; Specified dose on specified days; Other Names: Opdivo® BMS-936658

Outcome Measures

Primary Outcome Measures

1. Objective Response Rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 per Blinded Independent Central Review (BICR) in patients whose tumors have low programmed cell death ligand (PD-L1) expression [Approximately 18 months]

Secondary Outcome Measures

1. ORR by RECIST 1.1 per BICR in all treated patients [Approximately 18 months]

2. Duration of Response (DOR) by RECIST 1.1 per BICR in all treated patients and patients whose tumors have low PD-L1 expression [Approximately 2 years]

3. ORR and DOR by RECIST 1.1 per Investigator assessment in all treated patients and in patients whose tumors have low PD-L1 expression [Approximately 2 years]

4. Incidence of treatment-related Adverse Events (AEs) [Up to 2 years]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Key Inclusion Criteria:

• Provide written, informed consent to participate in the study and follow the study procedures

• Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2

• Measurable disease per RECIST 1.1 criteria

• Histologically or cytologically documented inoperable, locally advanced or metastatic urothelial cell carcinoma (also termed TCC)

• Fresh biopsy or archival tissue

• No prior systemic chemotherapy or investigational agent for inoperable locally advanced or mUC

• Ineligible for cisplatin

Key Exclusion Criteria:

• Patients who have an active, known or suspected autoimmune disease

• Patients must not have received prior IL-2 therapy

• Prior treatment with an anti PD-1, anti PD-L1, or anti cytotoxic T lymphocyte associated protein 4 (anti CTLA-4) antibody, agents that target IL-2 pathway, or any other antibody or drug specifically targeting T-cell co-stimulation or immune checkpoint pathways

• Patients with hypertension must be on a stable antihypertensive regimen for the 14 days prior to Cycle 1 Day 1

Additional protocol-defined inclusion/exclusion criteria will apply

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	San Francisco VA Medical Center - NAVREF - PPDS	San Francisco	California	United States	94143
2	Innovative Clinical Research Institute, LLC	Whittier	California	United States	90603
3	Rocky Mountain Cancer Centers	Aurora	Colorado	United States	80012
4	Winship Cancer Institute, Emory University	Atlanta	Georgia	United States	30322
5	Southeastern Regional Medical Center - CTCA - PPDS	Newnan	Georgia	United States	30265
6	Investigator Site - Peoria	Peoria	Illinois	United States	61615
7	Laura And Isaac Perlmutter Cancer Center	New York	New York	United States	10016
8	MD Anderson Cancer Center	Houston	Texas	United States	77030
9	Centro de Investigación Clínica - Clínica Viedma	Viedma	Rio Negro	Argentina	R8500ACE
10	Instituto de Oncologia de Rosario	Rosario	Santa Fe	Argentina	S2000DSK
11	CAIPO Centro para la atención integral del paciente oncológico	San Miguel De Tucumán	Tucumán	Argentina	4000
12	Hospital Alemán	Buenos Aires		Argentina	C1118AAT
13	Instituto Médico Especializado Alexander Fleming	Buenos Aires		Argentina	C1426ANZ
14	Centro Médico Privado CEMAIC	Córdoba		Argentina	X5000HHW
15	Sanatorio Privado Duarte Quirós, de Clínica Colombo S.A.	Córdoba		Argentina	X5002AOQ
16	St Vincent's Hospital Sydney	Darlinghurst	New South Wales	Australia	2010
17	Tasman Health Care	Southport	Queensland	Australia	4215
18	Adelaide Cancer Centre	Kurralta Park	South Australia	Australia	5037
19	Monash Health, Monash Medical Centre	Bentleigh East	Victoria	Australia	3165
20	St John of God Murdoch Hospital	Nedlands	Western Australia	Australia	6009
21	Algemeen Ziekenhuis Klina	Brasschaat	Antwerpen	Belgium	2930
22	GasthuisZusters Antwerpen	Wilrijk	Antwerpen	Belgium	2610
23	AZ Groeninge	Kortrijk		Belgium	8500
24	University Health Network	Toronto	Ontario	Canada	M5G 2M9
25	Helsingin Yliopistollinen Keskussairaala - PPDS	Helsinki		Finland	00290
26	Centre François Baclesse	Caen	Calvados	France	14076
27	Hôpital Privé TOULON/HYERES Sainte Marguerite	Hyères		France	83400
28	Centre Jean Bernard Clinique Victor Hugo	Le Mans		France	72015
29	Hôpital Européen Georges Pompidou	Paris		France	75908
30	Edog Ico - Ppds	Saint-Herblain		France	44805
31	Institut Gustave Roussy	Villejuif		France	94805
32	Studienpraxis Urologie	Nürtingen	Baden-Württemberg	Germany	72622
33	Kliniken Nordoberpfalz AG	Weiden	Bavaria	Germany	92637
34	Charité - Universitätsmedizin Berlin	Berlin		Germany	10117
35	Universitätsklinikum Carl Gustav Carus an der TU Dresden	Dresden		Germany	01307
36	Alexandra Hospital	Athens	Attiki	Greece	115 28
37	Medical Center of Athens	Maroúsi	Attiki	Greece	151 25
38	University General Hospital of Larissa	Larissa		Greece	41110
39	Euromedica - PPDS	Thessaloníki		Greece	54645
40	Shamir Medical Center Assaf Harofeh	Zerifin	HaMerkaz	Israel	70300
41	Rambam Medical Center - PPDS	Haifa		Israel	31096
42	Meir Medical Center	Kefar Saba		Israel	44281
43	Sheba Medical Center - PPDS	Ramat Gan		Israel	52621
44	Tel Aviv Sourasky Medical Center PPDS	Tel Aviv		Israel	52620
45	Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS	Meldola	Emilia-Romagna	Italy	47014
46	Centro Di Riferimento Oncologico	Aviano	Pordenone	Italy	33081
47	Istituto Nazionale Dei Tumori	Milano		Italy	20133
48	Health Pharma Professional Research S.A de C.V.	Ciudad de mexico	Distrito Federal	Mexico	03810
49	Phylasis Clinicas Research S. de R.L. de C.V.	Cuautitlán Izcalli		Mexico	54769
50	Het Nederlands Kanker Instituut Antoni Van Leeuwenhoek Ziekenhuis	Amsterdam		Netherlands	1066
51	Centro Hospitalar E Universitário de Coimbra EPE	Coimbra		Portugal	3000-075
52	Regional Clinical Oncology Hospital	Yaroslavl	Yaroslavskaya Oblast	Russian Federation	150040
53	Federal State Institution Medical Radiology Research Center	Obninsk		Russian Federation	249036
54	Clinical Oncology Dispensary	Omsk		Russian Federation	644013
55	PMI Euromedservice	Pushkin		Russian Federation	196603
56	Railway Clinical Hospital JSC RZhD	Saint Petersburg		Russian Federation	195271
57	Hospital General Universitario de Elche	Elche	Alicante	Spain	03203
58	Hospital de La Santa Creu i Sant Pau	Barcelona	Catalonia	Spain	08025
59	Hospital Universitario Ramon y Cajal	Pozuelo De Alarcón	Madrid	Spain	28223
60	Hospital del Mar	Barcelona		Spain	08003
61	Hospital Universitario 12 de Octubre	Madrid		Spain	28041
62	Hospital Universitario HM Sanchinarro - CIOCC	Madrid		Spain	28050
63	Hospital Universitario Virgen del Rocio - PPDS	Sevilla		Spain	41013
64	Fundacion Instituto Valenciano de Oncologia	Valencia		Spain	46009
65	Ankara University Medical Faculty - PPDS	Ankara		Turkey	6100
66	Izmir Medicalpark Hospital	İzmir		Turkey	35530
67	Inonu University Faculty of Medicine Turgut Ozal Medical Center	Malatya		Turkey	44280
68	Royal Marsden Hospital - Surrey	Sutton	Surrey	United Kingdom	SM2 5PT
69	Leicester Royal Infirmary	Leicester		United Kingdom	LE1 5WW
70	Barts Health NHS Trust	London		United Kingdom	EC1A 7BE

Sponsors and Collaborators

• Nektar Therapeutics
• Bristol-Myers Squibb

Investigators

• Study Director: Study Director, Nektar Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Nektar Therapeutics
• ClinicalTrials.gov Identifier: NCT03785925
• Other Study ID Numbers: 18-214-10; CA045-012; 2018-003636-79
• First Posted: Dec 24, 2018
• Last Update Posted: Jul 26, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Nektar Therapeutics: Bladder; Bladder Cancer; CD122; Cisplatin Ineligible; Immuno-oncology; Immunotherapy; Locally Advanced Urothelial Cancer; Metastatic Urothelial Cancer; mUC; Natural Killer Cells; Nivolumab; NKTR-214; Opdivo®; PD-L1; Urothelial Cancer; Urothelial; Metastatic Urothelial Carcinoma; Urothelial Carcinoma; Bempegaldesleukin; BEMPEG; CPI Combination; IL-2
• Additional relevant MeSH terms: Neoplasms; Neoplasm Metastasis; Urinary Bladder Neoplasms; Nivolumab

Study Results

No Results Posted as of Jul 26, 2022