臨床研究等提出・公開システム

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

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

Kawai Norisuke

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

clinical-trials@pfizer.com

Clinical Trials Information Desk

Pfizer R&D Japan G.K.

Shinjuku Bunka Quint Bldg., 3-22-7 Yoyogi, Shibuya-ku, Tokyo

+81-3-5309-7000

clinical-trials@pfizer.com

Not Recruiting

Sept. 29, 2021

Interventional

non-randomized controlled trial

open(masking not used)

uncontrolled control

parallel assignment

treatment purpose

Inclusion Criteria:
1.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.
2.Participants must agree to follow the reproductive criteria.
3.Participants must be willing and able to comply with all scheduled visits, treatment plan, and other study procedures.

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

Both

Malignant Tumor

Arm 1: Avelumab
Arm 2: Avelumab, CPM 001, Utomilumab, PF-04518600
Arm 3: Avelumab, Lorlatinib
Arm 4: Avelumab
Arm 5: Avelumab, Pemetrexed
Arm 6: Avelumab, Talazoparib
Arm 7: Avelumab, Axitinib
Arm 8: Avelumab, Talazoparib

Primary Outcome Measures :
1.Number of participants with adverse events leading to permanent discontinuation of study intervention [ Time Frame: Baseline up to approximately 5 years ]
2.Number serious adverse events reported for all participants [ Time Frame: Baseline up to approximately 5 years ]

+81-3-3520-0111

Sept. 07, 2021

Yes

Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Australia/Belgium/Canada/Denmark/France/Hungary/Israel/Italy/Korea, Republic of/Mexico/New Zealand/Poland/Russian Federation/Serbia/Spain/Taiwan/United Kingdom/United States