Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

All Conditions

Symptoms and General Pathology

Digestive System Diseases

Rare Diseases

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Recurrence

Peritoneal Neoplasms

Fallopian Tube Neoplasms

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Fallopian Tube Diseases

Abdominal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Peritoneal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Fallopian Tube Cancer

Antineoplastic Agents

All Drugs and Chemicals

Anti-Infective Agents

Doxorubicin

Liposomal doxorubicin

Taxane

Epothilone B

Epothilones

Anti-Bacterial Agents

Antibiotics, Antitubercular

Enzyme Inhibitors

Tubulin Modulators

Antimitotic Agents

EPO906 (Patupilone)

doxorubicin

Novartis Pharmaceuticals

The objective of this study is to assess the safety and efficacy of patupilone compared to pegylated liposomal doxorubicin. Additionally, this study will assess the ability of patupilone to extend the survival time and potential beneficial effects in women who have nonresponsive or recurrent ovarian, primary fallopian, or primary peritoneal cancer.

Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer

A Randomized, Parallel Group, Open-label, Active Controlled, Multicenter Phase III Trial of Patupilone (EPO906) Versus Pegylated Liposomal Doxorubicin in Taxane/Platinum Refractory/Resistant Patients With Recurrent Epithelial Ovarian, Primary Fallopian or Primary Peritoneal Cancer

Neoplasms, Second Primary

Disease Attributes

Dostarlimab

4 intravenous injections maximum of dostarlimab, 500mg, every 3 weeks

Dostarlimab should initiated within 6 months after the end of treatment for FPC.

Jean-Yves BLAY, MD, PhD

Zoé NEVIERE

Xavier DURANDO

Jean-Yves BLAY, MD,PhD

Victor SARRADIN

Thomas PUDLARZ

PredoSTAR is a multicenter, randomized, open-label phase II study proposed to patients at high risk of SPC and in whom the treatment of the FPC does not include immunotherapy. Dostarlimab treatment will be started within 6 months after the completion of treatment for localized FPC (i.e. after the end of last CT, RT cure or surgery with a wash-out period of 4 weeks before to start Dostarlimab). Eligible patients will be randomized (1:1) to receive:

* Arm Dostarlimab : 4 intravenous (IV) injections of dostarlimab, Q3W or
* Arm No treatment

Analysis will be performed according the ITT principe and will include all randomized patients. Incidence of events by arm will be compared assuming a Poisson distribution. Cumulative incidence curves against time will we compared between treatment arms. Follow-up of each patient will be calculated from randomisation to death or last follow-up for alive patients.

PREventing Second Cancers With DOSTARlimab

A Multicenter, Open-label, Randomized Phase II Study Aiming to Assess the Clinical Impact of Dostarlimab on Occurrence of Second Primary Cancer in Patients With Cured Primary Cancer

Second primary invasive cancer must be centrally histologically confirmed

Only for Arm A : any AEs graded using Common Terminology Criteria for Adverse Events (CTCAE) V5.0.

GlaxoSmithKline

Centre Leon Berard

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer	NCT00262990	Ovarian Cancer Fallopian Tube ... Peritoneal Neop...	EPO906 (Patupil... doxorubicin	18 Years -	Novartis
PREventing Second Cancers With DOSTARlimab	NCT05855811	Recurrent Cance... Primary Cancer Second Cancer	Dostarlimab	18 Years -	Centre Leon Berard
Patupilone Versus Doxorubicin in Patients With Ovarian, Primary Fallopian, or Peritoneal Cancer	NCT00262990	Ovarian Cancer Fallopian Tube ... Peritoneal Neop...	EPO906 (Patupil... doxorubicin	18 Years -	Novartis
PREventing Second Cancers With DOSTARlimab	NCT05855811	Recurrent Cance... Primary Cancer Second Cancer	Dostarlimab	18 Years -	Centre Leon Berard

Spots Global Cancer Trial Database for primary cancer