Informations générales (source: ClinicalTrials.gov)
An Open-label, Multicenter, Randomized Phase 2 Study of the ATR Inhibitor Tuvusertib in Combination With the PARP Inhibitor Niraparib or the ATM Inhibitor Lartesertib in Participants With BRCA Mutant and/or Homologous Recombination deficiency (HRD)-Positive Epithelial Ovarian Cancer That Progressed on Prior PARP Inhibitor Therapy (DDRiver EOC 302)
Interventional
Phase 2
EMD Serono Research & Development Institute, Inc. (Voir sur ClinicalTrials)
octobre 2024
janvier 2028
05 avril 2025
The purpose of this study is to measure the effect and safety of treatment with
tuvusertib combined with either niraparib or lartesertib in participants with epithelial
ovarian cancer. The participants will previously have progressed while treated with a
poly ADP ribose polymerase (PARP) inhibitor. The primary objective of the study is to
assess the effect of the treatment in terms of overall response, i.e. whether the tumor
disappears, shrinks, remains unchanged, or gets worse.
Etablissements
| Les établissements d'Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| AP-HP - Hôpital Cochin | Contact (sur clinicalTrials) | ||||
| AP-HP - Hôpital Tenon | Contact (sur clinicalTrials) | ||||
| GH PARIS SITE SAINT JOSEPH | Contact (sur clinicalTrials) | ||||
| GRPE HOSP DIACONESSES-CROIX ST-SIMON | Contact (sur clinicalTrials) | ||||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| Centre de Radiotherapie Clinique Sainte Anne - 300207251 - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Centre Francois Baclesse - Service d'Oncologie Medicale - Caen Cedex 05 - France | Contact (sur clinicalTrials) | ||||
| Centre Hospitalier Lyon Sud - service d'oncologie medicale - Pierre Benite cedex - France | Contact (sur clinicalTrials) | ||||
| Centre Leon Berard - Service d'Oncologie Medicale - Lyon - France | Contact (sur clinicalTrials) | ||||
| Centre Oscar Lambret - service de cancerologie gynecologique - Lille cedex - France | Contact (sur clinicalTrials) | ||||
| ICO - Site Paul Papin - service d'oncologie medicale - Angers Cedex 2 - France | Contact (sur clinicalTrials) | ||||
| Institut de Cancérologie de Strasbourg Europe - ICANS - Service d'oncologie médicale - Strasbourg - France | Contact (sur clinicalTrials) | ||||
| Institut Gustave Roussy - Oncologie Médicale - Villejuif - France | Contact (sur clinicalTrials) | ||||
Critères
Femme
Inclusion Criteria:
- Histologically or cytologically confirmed high grade serous or high grade
endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is
recurrent.
- Participants whose tumor carries germline or somatic deleterious or suspected
deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast
Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these
mutations and/or the homologous recombination deficiency (HRD) status will be
determined according to routinely used local standard of care tests. Results must be
available before screening.
- Radiologically confirmed/documented disease progression while on Poly (ADP-ribose)
polymerase (PARP) inhibitors therapy in either first or second-line maintenance
setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab).
Note: Documentation of disease progression must be within 28 days of last PARPi dose
taken. Surgical salvage intervention and/or focal ablative therapies are allowed,
(further disease progression after these interventions must be documented), AND
Clinically benefited from PARPi maintenance prior to documented progression, as
defined by at least 6 months of treatment duration with no progressive disease
observed, AND either, Progression on first-line maintenance PARPi: Participants are
allowed maximum 1 additional line of platinum-based chemotherapy before study entry.
(note: treatment-free interval on platinum rechallenge must be >6 months, with
documented disease progression prior to study entry).
OR Progression on second-line maintenance PARPi: Participants are not allowed any
additional systemic anticancer treatments before study entry (that is PARPi is the last
treatment before study entry)
- Measurable disease per RECIST v1.1, as assessed by Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life
expectancy of at least 6 months.
- Other Protocol defined inclusion criteria could apply.
- Histologically or cytologically confirmed high grade serous or high grade
endometrioid ovarian, primary peritoneal, and/or fallopian tube cancer that is
recurrent.
- Participants whose tumor carries germline or somatic deleterious or suspected
deleterious mutations in the genes BRCA1 (Breast Cancer gene 1) and BRCA2 (Breast
Cancer gene 2), and/or tumors with positive HRD status. The presence of any of these
mutations and/or the homologous recombination deficiency (HRD) status will be
determined according to routinely used local standard of care tests. Results must be
available before screening.
- Radiologically confirmed/documented disease progression while on Poly (ADP-ribose)
polymerase (PARP) inhibitors therapy in either first or second-line maintenance
setting (only 1 line of PARPi maintenance is allowed with or without bevacizumab).
Note: Documentation of disease progression must be within 28 days of last PARPi dose
taken. Surgical salvage intervention and/or focal ablative therapies are allowed,
(further disease progression after these interventions must be documented), AND
Clinically benefited from PARPi maintenance prior to documented progression, as
defined by at least 6 months of treatment duration with no progressive disease
observed, AND either, Progression on first-line maintenance PARPi: Participants are
allowed maximum 1 additional line of platinum-based chemotherapy before study entry.
(note: treatment-free interval on platinum rechallenge must be >6 months, with
documented disease progression prior to study entry).
OR Progression on second-line maintenance PARPi: Participants are not allowed any
additional systemic anticancer treatments before study entry (that is PARPi is the last
treatment before study entry)
- Measurable disease per RECIST v1.1, as assessed by Investigator.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 and a life
expectancy of at least 6 months.
- Other Protocol defined inclusion criteria could apply.
- Primary platinum-refractory disease defined as disease progression during primary
platinum-based chemotherapy or platinum-resistant disease defined as disease
progression within 6 months of the last platinum administration in the second-line
setting.
- History of additional malignancy within 3 years before the date of enrollment.
- Known brain metastases, unless clinically stable, that is without evidence of
progression by imaging for at least 4 weeks prior to the first dose of study
intervention, no evidence of new brain metastases, and on a stable or decreasing
dose of ≤ 10 mg of prednisone (or equivalent) or without corticosteroids for at
least 14 days prior to study intervention administration.
- Active and/or uncontrolled infection.
- History of known hypersensitivity to the active substances or to any excipients
(e.g. polysorbate 80) of the study interventions.
- Organ transplantation, including allogenic stem cell transplant.
- Other Protocol defined exclusion criteria could apply.