- Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- Subjects with histologically or cytologically documented high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer.
- Subjects must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen.
- Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy:
Neoadjuvant ± adjuvant considered 1 line of therapy.
Maintenance therapy (eg, bevacizumab, poly-ADP ribose polymerase [PARP] inhibitors) will be considered part of the preceding line of therapy.
Therapy changed due to toxicity in the absence of progression will be considered part of the same line. (Hormonal therapy will be counted as a separate line of therapy, unless it was given as maintenance.)
At least 1 line of therapy containing bevacizumab, unless the subject is not eligible for treatment with bevacizumab due to precautions/intolerance.
- Has platinum-resistant disease.
If a subject had only 1 line of platinum therapy, must have received at least 4 cycles of platinum, must have had a best response of not PD, and then progressed between >90 and ≤180 days after the date of the last dose of platinum
If a subject had 2 or 3 lines of platinum therapy, must have received at least 2 cycles of platinum and have progressed on or within 180 days after the date of the last dose of platinum
- Has had prior PARP inhibitors for subjects with documented breast cancer gene (BRCA) mutation (germline and/or somatic), unless the subject is not eligible for treatment with a PARP inhibitor.
- Has had prior treatment with mirvetuximab soravtansine for subjects with documented high folate receptor alpha expression, unless the subject is not eligible for treatment with mirvetuximab soravtansine due to precautions/intolerance, or if the treatment is not approved or available locally.
Source : Importé depuis le centre
Critères d'exclusion
- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC.
- Inadequate washout period before Cycle 1 Day 1, defined as follows:
Major surgery <28 days
Radiation therapy <28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)
Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) <28 days or 5 half-lives, whichever is shorter, before starting study drug
Chloroquine/hydroxychloroquine <14 days
Exposure to another investigational drug within 28 days prior to start of study treatment or current participation in other therapeutic investigational procedures
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the
study if they have recovered from the acute toxic effect of radiotherapy, at the investigator’s discretion.
Nous verifions auprès de chaque centre si des nouvelles informations sont disponibles
Identifiant
REJOICE DS6000-109
Titre
Une étude multicentrique randomisée de phase 2/3 sur le raludotatug deruxtecan (r-dxd), un conjugué anticorps-médicament dirigé contre cdh6, chez des sujets atteints de cancer de l'ovaire, du péritoine primaire ou des trompes de fallope de haut grade et résistants au platine (optimisation de la dose et étude de phase 3 de r-dxd versus choix de chimiothérapie de l'investigateur chez des patients atteints de cancer de l'ovaire résistant au platine)
Source : traduction non-officielle opérée par intelligence artificielle
voir le texte original
A Phase 2/3, Multicenter, Randomized Study of Raludotatug Deruxtecan (R-DXd), a CDH6-directed Antibody-drug Conjugate, in Subjects with Platinum-resistant, High-grade Ovarian, Primary Peritoneal, or Fallopian Tube Cancer
(Dose Optimization and Phase 3 Study of R-DXd versus Investigator’s Choice of Chemotherapy in Platinum resistant Ovarian Cancer)
- Age ≥18 years or the minimum legal adult age (whichever is greater) at the time the ICF is signed.
- Subjects with histologically or cytologically documented high-grade serous OVC, high-grade endometrioid OVC, primary peritoneal cancer, or fallopian tube cancer.
- Subjects must have at least 1 lesion, not previously irradiated, amenable to biopsy, and must consent to provide a pretreatment biopsy and on-treatment biopsy tissue sample (on-treatment biopsy sample not required for the Phase 3 part of the study). Fresh pretreatment biopsy may be waived for subjects who consent to provide an archival tumor tissue sample from a lesion not previously irradiated, performed within 6 months of consent, and performed after treatment with their most recent cancer therapy regimen.
- Has received at least 1 but no more than 3 prior systemic lines of anticancer therapy:
Neoadjuvant ± adjuvant considered 1 line of therapy.
Maintenance therapy (eg, bevacizumab, poly-ADP ribose polymerase [PARP] inhibitors) will be considered part of the preceding line of therapy.
Therapy changed due to toxicity in the absence of progression will be considered part of the same line. (Hormonal therapy will be counted as a separate line of therapy, unless it was given as maintenance.)
At least 1 line of therapy containing bevacizumab, unless the subject is not eligible for treatment with bevacizumab due to precautions/intolerance.
- Has platinum-resistant disease.
If a subject had only 1 line of platinum therapy, must have received at least 4 cycles of platinum, must have had a best response of not PD, and then progressed between >90 and ≤180 days after the date of the last dose of platinum
If a subject had 2 or 3 lines of platinum therapy, must have received at least 2 cycles of platinum and have progressed on or within 180 days after the date of the last dose of platinum
- Has had prior PARP inhibitors for subjects with documented breast cancer gene (BRCA) mutation (germline and/or somatic), unless the subject is not eligible for treatment with a PARP inhibitor.
- Has had prior treatment with mirvetuximab soravtansine for subjects with documented high folate receptor alpha expression, unless the subject is not eligible for treatment with mirvetuximab soravtansine due to precautions/intolerance, or if the treatment is not approved or available locally.
Source : Importé depuis le centre
Critères d'exclusion
- Has clear cell, mucinous, or sarcomatous histology, mixed tumors containing any histology, or low-grade/borderline OVC.
- Inadequate washout period before Cycle 1 Day 1, defined as follows:
Major surgery <28 days
Radiation therapy <28 days (if palliative stereotactic radiation therapy without abdominal radiation, ≤14 days)
Systemic anticancer therapy (including antibody-drug therapy, retinoid therapy, and hormonal therapy) <28 days or 5 half-lives, whichever is shorter, before starting study drug
Chloroquine/hydroxychloroquine <14 days
Exposure to another investigational drug within 28 days prior to start of study treatment or current participation in other therapeutic investigational procedures
- Clinically active brain metastases, spinal cord compression, or leptomeningeal carcinomatosis, defined as untreated or symptomatic, or requiring therapy with steroids or anticonvulsants to control associated symptoms. Subjects with untreated and asymptomatic brain metastases or subjects with treated brain metastases who are no longer symptomatic and who require no treatment with steroids may be included in the
study if they have recovered from the acute toxic effect of radiotherapy, at the investigator’s discretion.
