Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing

Sponsor

Pfizer (Industry)

Overall Status

Recruiting

CT.gov ID

NCT05059522

Collaborator

(none)

262

Enrollment

Locations

Arms

37.6

Anticipated Duration (Months)

12.5

Patients Per Site

0.3

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

This Master Protocol for Avelumab Continuation Sub-Studies is to provide continued treatment access, safety follow-up, and when applicable, overall survival follow-up for eligible participants who continue to derive a benefit from study intervention in the Pfizer-sponsored Avelumab parent studies.

Condition or Disease	Intervention/Treatment	Phase
Advanced Malignancies NSCLC Ovarian Cancer Urothelial Cancer Solid Tumors	Drug: Avelumab Drug: Lorlatanib Drug: Talazoparib Drug: Pemetrexed Drug: Axitinib Drug: CMP 001 Drug: Utomilumab Drug: PF04518600	Phase 3

Detailed Description

B9991046 is a master protocol that will consist of sub-studies from the following parent studies:

B9991001 - NCT02603432 B9991004 - NCT02554812 B9991005 - NCT02584634 B9991009 - NCT02580058 B9991023 - NCT03317496 B9991025 - NCT03330405 B9991027 - NCT03472560 B9991032 - NCT03565991

Study Design

Study Type:

Interventional

Anticipated Enrollment :

262 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Avelumab Master Protocol: An Open-label Continuation Study for Participants Continuing From Pfizer-sponsored Avelumab Clinical Studies.

Actual Study Start Date :

Sep 29, 2021

Anticipated Primary Completion Date :

Nov 17, 2024

Anticipated Study Completion Date :

Nov 17, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Arm 1 Avelumab monotherapy as specified by sub-study protocol B9991001C	Drug: Avelumab oral
Experimental: Arm 2 Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C	Drug: Avelumab oral Drug: CMP 001 IT (intratumoral) or SC (subcutaneous) Drug: Utomilumab IV infusion Drug: PF04518600 IV infusion
Experimental: Arm 3 Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C	Drug: Avelumab oral Drug: Lorlatanib oral
Experimental: Arm 4 Avelumab monotherapy as specified by sub-study protocol B9991009C	Drug: Avelumab oral
Experimental: Arm 5 Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C	Drug: Avelumab oral Drug: Pemetrexed IV (intravenous) infusion
Experimental: Arm 6 Avelumab in combination with Talazoparib as specified by sub-study B9991025C.	Drug: Avelumab oral Drug: Talazoparib oral
Experimental: Arm 7 Avelumab in combination with Axitinib as specified by sub-study B9991027C.	Drug: Avelumab oral Drug: Axitinib oral
Experimental: Arm 8 Avelumab in combination with Talazoparib as specified by sub-study B9991032C.	Drug: Avelumab oral Drug: Talazoparib oral

Outcome Measures

Primary Outcome Measures

Number of participants with adverse events leading to permanent discontinuation of study intervention [Baseline up to approximately 5 years]
Number serious adverse events reported for all participants [Baseline up to approximately 5 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Any participant who is receiving study treatment and deriving significant clinical benefit or is in the safety and/or survival follow-up period in a Pfizer-sponsored Avelumab Parent Study.
Participants must agree to follow the reproductive criteria.
Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

Exclusion Criteria:

Female participants who are pregnant or breastfeeding.
Any medical reason that, in the opinion of the Investigator or Sponsor, precludes the participant from inclusion in the study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Highlands Oncology Group, PA	Springdale	Arkansas	United States	72762
2	The University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030
3	The Prince Charles Hospital	Chermside	Queensland	Australia	4032
4	Grand Hôpital de Charleroi	Charleroi	Hainaut	Belgium	6000
5	UZ Gent	Gent	Oost-vlaanderen	Belgium	9000
6	Kingston Health Sciences Centre-Kingston General Hospital Site	Kingston	Ontario	Canada	K7L 2V7
7	Institut de Cancérologie de Lorraine Alexis Vautrin	Vandoeuvre-lès-Nancy	Lorraine	France	54519
8	Országos Onkológiai Intézet	Budapest		Hungary	1122
9	Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I - G.M. Lancisi - G. Salesi	Ancona		Italy	60126
10	AOU Policlinico Umberto I	Roma		Italy	00161
11	National Cancer Center Hospital	Chuo-ku	Tokyo	Japan	104-0045
12	Japanese Foundation for Cancer Research	Koto	Tokyo	Japan	135-8550
13	National Hospital Organization Kyushu Cancer Center	Fukuoka		Japan	811-1395
14	Oita University Hospital	Yufu	Ōita	Japan	879-5593
15	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [incheon]	Korea, Republic of	21565
16	Asan Medical Center	Seoul	Seoul-teukbyeolsi [seoul]	Korea, Republic of	05505
17	GBUZ SK Pyatigorsk Interdistrict Oncology dispensary	Pyatigorsk	Stavropol'skiy KRAY	Russian Federation	357502
18	Hospital Universitari Vall d'Hebron	Barcelona	Barcelona [barcelona]	Spain	08035
19	Hospital Clínic de Barcelona	Barcelona	Barcelona [barcelona]	Spain	08036
20	Hospital Universitario Fundación Jiménez Díaz	Madrid		Spain	28040
21	Hospital Universitario Virgen de Valme	Sevilla		Spain	41014