Neoplasms

Symptoms and General Pathology

All Conditions

Skin and Connective Tissue Diseases

Heart and Blood Diseases

Rare Diseases

Neoplasm Metastasis

Sclerosis

Scleroderma, Systemic

Scleroderma, Diffuse

Raynaud Disease

Neoplastic Processes

Connective Tissue Diseases

Skin Diseases

Vascular Diseases

Livedoid Vasculopathy

Thrombosis

Embolism

Embolism and Thrombosis

Peripheral Arterial Disease

Peripheral Vascular Diseases

Skin Diseases, Vascular

Systemic Scleroderma

Acute Graft Versus Host Disease

Vasodilator Agents

Platelet Aggregation Inhibitors

Urological Agents

All Drugs and Chemicals

Alprostadil

300 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

1000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, one dispenser for each administration

3000 micrograms/.42% Alprostadil Cream with 2.5% Dodecyl-2-N,N-dimethylaminopropionate hydrochloride (DDAIP-HCl) and Placebo, two dispensers for each administration

Placebo

Barbara Troupin, MD, MBA

The purpose of this study is to evaluate pharmacodynamics (PD) in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).

The purpose of this study is to evaluate the pharmacodynamic (PD) effects of topical Alprostadil on digital perfusion by laser Doppler capillary velocimetry and digital temperature recovery with thermography following standardized cold challenge and to assess the safety and tolerability of 3 doses of Alprostadil topical cream and placebo cream in adult subjects with a diagnosis of Raynaud's Phenomenon secondary to Systemic Sclerosis (SSc).

Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis

A Phase 2a Double-Blind, Randomized, Placebo-Controlled Crossover Trial of the Acute Peripheral Vascular Effects, Safety and Tolerability of Alprostadil Topical Cream in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis (SSc, Scleroderma)

NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Urinary Bladder Neoplasms

Non-Muscle Invasive Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Carcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Antibodies

Antibodies, Monoclonal

Immunomodulating Agents

Immunoglobulins

BCG Vaccine

Vaccines

Adjuvants, Immunologic

Immunologic Factors

PF-06801591 in combination with Bacillus Calmette Guerin(induction+maintenance).

PF-06801591 in combination with Bacillus Calmette Guerin (induction only).

Bacillus Calmette Guerin (induction and maintenance).

A monoclonal antibody (mAb) that blocks the interaction between PD-1 and PD-L1/PD-L2.

PF-06801591

Immunotherapy treatment approved by FDA for patients with high-risk non-muscle invasive bladder cancer

Bacillus Calmette-Guerin

Pfizer CT.gov Call Center

The purpose of this study is to learn about the safety and effects of the study medicine (sasanlimab) in people with non-muscle invasive bladder cancer. This study is seeking participants whose bladder cancer is still in early stages, has not spread outside of the bladder, has been removed with surgery, and is high risk (Part A) or was previously treated with BCG (Bacillus Calmette Guerin), a standard treatment for bladder cancer (Part B).

In Part A (enrollment closed), each participant was assigned to one of three study treatment groups.

* One group is given sasanlimab and BCG at the study clinic.
* The second group is given sasanlimab and BCG at the study clinic. This group will receive BCG for the first six weeks only.
* The third group is given BCG only and will not receive sasanlimab.

In Part B of the study, each new participant will be assigned to a study treatment group based on the type of their bladder tumor.

- Both groups will be given sasanlimab at the study clinic.

On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B. The decision to discontinue enrollment to Part B was not made for safety reasons.

CREST: Combination of sasanlimab and alternative BCG Regimens to Evaluate outcomes with Subcutaneous anti-PD-1 Treatment

Phase 3 Design with two Cohorts. Cohort A consists of 3 study Arms (A, B and C) of BCG naive participants. Arms A and B consist of two study drugs, PF-06801591 plus BCG. Arm C consists of one study drug, BCG. Cohort B consists of B1 and B2, which test PF-06801591 and include participants who have BCG unresponsive CIS (B1) or BCG unresponsive papillary only disease (B2).

The study is designed to demonstrate that PF-06801591 plus Bacillus Calmette Guerin (BCG) (induction and maintenance periods) is superior to BCG alone (induction and maintenance periods) in prolonging event free survival (EFS) in participants with high-risk naïve non-muscle invasive bladder cancer (NMIBC) and to demonstrate that PF-06801591 plus BCG (induction period only) is superior to BCG alone (induction and maintenance periods) in prolonging EFS in participants with high-risk NMIBC. The study is also designed to estimate the CR rate of PF-06801591 alone in participants with BCG unresponsive CIS and to evaluate the EFS of PF-06801591 alone in participants with BCG unresponsive NMIBC.

On August 31, 2022, the Sponsor announced the discontinuation of enrollment to Part B, which enrolled participants with BCG unresponsive NMIBC. The decision to discontinue enrollment to Part B was not made for safety reasons.

A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer

A Phase 3, Multinational, Randomized, Open-Label, Three Parallel-Arm Study of PF-06801591, an Anti-PD-1 Antibody, in Combination With Bacillus Calmette-Guerin (BCG Induction With or Without BCG Maintenance) Versus BCG (Induction and Maintenance) in Participants With High-Risk, BCG-Naïve Non-Muscle Invasive Bladder Cancer or PF-06801591 as a Single Agent in Participants With BCG-Unresponsive NMIBC

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.

Event free survival is defined as the time from randomization to date of EFS event.

Complete response (CR) rate defined as the proportion of participants in the analysis population with CR.

Event free survival is defined as the time from first dose to date of EFS event.

Overall survival is defined as the time from the date of randomization to the date of death due to any cause.

Disease specific survival (DSS) is defined as the time from randomization to death resulting from bladder cancer.

EORTC QLQ-C30: included functional scales (physical, role, cognitive, emotional, and social), global health status, symptom scales (fatigue, pain, nausea/vomiting) and single items (dyspnoea, appetite loss, insomnia, constipation/diarrhea and financial difficulties).

Ctrough will be summarized in Cohort A Arms A and B only.

Immunogenicity will be evaluated for Cohort A Arms A and B only.

Duration of CR is defined as time from first CR to first recurrence or death due to any cause, whichever occurs first.

Time to recurrence defined as time from randomization to the date of first documentation of recurrence of low grade disease or death due to any cause, whichever occurs first.

Time to cystectomy is defined as time from randomization/registration to cystectomy in participants with NMIBC

PTAB is a 2-item PRO designed to assess, from the patient perspective, any pain associated with the treatment administration and the burden of the amount of time required to complete the treatment administration procedures (1 item each).

An adverse event (AE) is any untoward medical occurrence attributed to study drug in a participant who received study drug. AEs comprised both SAEs and non-SAEs. Causality assessment is made by the investigator. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.

Percentage of participants with laboratory test abnormalities without regard to baseline abnormality. Grading is per the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Event (CTCAE) version 3.0.

EORTC-QLQ-NMIBC24 has 24 items which can be grouped into 6 subscales: urinary symptoms (7 items), malaise (2 items), future worries (4 items), bloating/flatulence (2 items), sexual functioning (2 items), and male sexual issues (2 items). The NMIBC24 also assesses intravesical treatment, female sexual issues, sexual intimacy, risk of contaminating a partner, and sexual enjoyment (1 item each).

Complete response (CR) rate defined as the proportion of participants in the analysis population with CR at 12 months.

Time from first dose to date of EFS event.

Time from the date of first dose to the date of death due to any cause.

Immunogenicity will be evaluated for participants with BCG unresponsive NMIBC, including those with CIS.

Cmax will be summarized in Cohort B2 only.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)
A Study of Sasanlimab in People With Non-muscle Invasive Bladder Cancer	NCT04165317	Non-muscle Inva...	PF-06801591 Bacillus Calmet...	18 Years -	Pfizer
Study of Acute Peripheral Vascular Effects, Safety and Tolerability in Subjects With Raynaud's Phenomenon Secondary to Systemic Sclerosis	NCT02228850	Raynaud's Pheno...	Alprostadil Placebo	18 Years - 79 Years	NexMed (U.S.A.), Inc. (subsidiary of Apricus Biosciences, Inc.)

Spots Global Cancer Trial Database for crest

Every month we try and update this database with for crest 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 crest

Every month we try and update this database with for crest 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 crest 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.