Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Ovarian Cancer

Ovarian Epithelial Cancer

Antineoplastic Agents

All Drugs and Chemicals

Micronutrients

Hematinics

Vitamins

Pemetrexed

Avelumab

Axitinib

Talazoparib

Enzyme Inhibitors

Folic Acid

Vitamin B Complex

Folic Acid Antagonists

Antineoplastic Agents, Immunological

Protein Kinase Inhibitors

Poly(ADP-ribose) Polymerase Inhibitors

Folinic Acid

Folate

Vitamin B9

Avelumab monotherapy as specified by sub-study protocol B9991001C

Avelumab in combination with CMP 001, Utomilumab or PF04518600 as specified by sub-study protocol B9991004C

Avelumab in combination with Loratanib as specified by sub-study protocol B9991005C

Avelumab monotherapy as specified by sub-study protocol B9991009C

Avelumab monotherapy or in combination with Pemetrexed as specified by sub-study protocol B9991023C

Avelumab in combination with Talazoparib as specified by sub-study B9991025C.

Avelumab in combination with Axitinib as specified by sub-study B9991027C.

Avelumab in combination with Talazoparib as specified by sub-study B9991032C.

Lorlatanib

CMP 001

Utomilumab

PF04518600

Pfizer CT.gov Call Center

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.

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

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

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

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.

Pfizer

Blood and Lymph Conditions

Immune System Diseases

Lymphoma

Lymphoma, Follicular

Neoplasms by Histologic Type

Lymphoproliferative Disorders

Lymphatic Diseases

Immunoproliferative Disorders

Lymphoma, Non-Hodgkin

Lymphosarcoma

Follicular Lymphoma

Antirheumatic Agents

Rituximab

Immunomodulating Agents

Immunologic Factors

* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* Avelumab is administered intravenously over 1 hour once every 2 weeks

* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Utomilumab is administered intravenously over 1 hour once every 4 weeks
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15

* Rituximab is administered intravenously per institutional standards for four weekly treatments for cycle 1 only
* Avelumab is administered intravenously over 1 hour once every 2 weeks
* PF-04518600 is administered intravenously over 1 hour on day 1 and day 15

Rituximab works by targeting the CD20 antigen on normal and malignant B-cells. Then the body's natural immune defenses are recruited to attack and kill the marked B-cells. Stem cells (young cells in the bone marrow that will develop into the various types of cells) do not have the CD20 antigen. This allows healthy B-cells to regenerate after treatmen

Utomilumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug

Avelumab is a drug which may stimulate the immune system against tumor cells. Because it activate the immune system, it is sometimes called immunotherapy drug

In the presence of tumor-associated antigens (TAAs), this may promote a T-cell-mediated immune response against TAA-expressing tumor cells. OX40

Caron A. Jacobson, MD

This research study is studying several new investigational drug combinations as a possible treatment for follicular lymphoma.

The drugs involved are:

* Rituximab
* Utomilumab
* Avelumab

This research study is a Phase 1 clinical trial. Phase 1 clinical trials test the safety of an investigational intervention and also try to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.

Utomilumab and avelumab are drugs which may stimulate the immune system against tumor cells. Because they activate the immune system, they are sometimes called immunotherapy drugs. The FDA (the U.S. Food and Drug Administration) has not approved utomilumab or avelumab for treatment of this cancer.

Rituximab is approved by the FDA (the U.S. Food and Drug Administration) as a treatment option for this disease.

The purpose of this research is to learn about the effects of combining the immunotherapy drugs utomilumab and avelumab with rituximab in follicular lymphoma. The investigators hope to learn how safe the combinations of treatments are for participants with follicular lymphoma.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing	NCT05059522	Advanced Malign... NSCLC Ovarian Cancer Urothelial Canc... Solid Tumors	Avelumab Lorlatanib Talazoparib Pemetrexed Axitinib CMP 001 Utomilumab PF04518600	18 Years -	Pfizer
RITUXIMAB + IMMUNOTHERAPY IN FOLLICULAR LYMPHOMA	NCT03636503	Follicular Lymp...	Rituximab Utomilumab Avelumab PF04518600	18 Years -	Dana-Farber Cancer Institute
RITUXIMAB + IMMUNOTHERAPY IN FOLLICULAR LYMPHOMA	NCT03636503	Follicular Lymp...	Rituximab Utomilumab Avelumab PF04518600	18 Years -	Dana-Farber Cancer Institute
Continued Access Study for Participants Deriving Benefit in Pfizer-Sponsored Avelumab Parent Studies That Are Closing	NCT05059522	Advanced Malign... NSCLC Ovarian Cancer Urothelial Canc... Solid Tumors	Avelumab Lorlatanib Talazoparib Pemetrexed Axitinib CMP 001 Utomilumab PF04518600	18 Years -	Pfizer

Spots Global Cancer Trial Database for pf04518600

Every month we try and update this database with for pf04518600 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for pf04518600

Every month we try and update this database with for pf04518600 cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for pf04518600 cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.