Study to Assess the Efficacy and Safety of Rina-S Compared to Treatment of Investigator's Choice in Participants With Endometrial Cancer
A legfontosabb adatok
- Hol
- Calgary, Montreal és Vancouver (Kanada)Mind a 3 helyszín megnézése
- Fázis
- 3. fázis
AI-kivonat: kiket keres a vizsgálat
A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.
A vizsgálat olyan nőket keres, akiknek a méhnyálkahártya-rákja a platinaalapú kemoterápia és egy PD(L)-1-gátló után visszatért vagy rosszabbodott. A Rina-S-t paclitaxellel vagy doxorubicinnel hasonlítják össze.
- Életkor
- 18 éves vagy idősebb
- Nem
- Csak nők
- A betegség stádiuma
- Visszatérő vagy előrehaladó méhnyálkahártya-rák, amely az utolsó kezelés alatt vagy után a képalkotó vizsgálaton nőtt. A neuroendokrin daganatok, a carcinosarcoma és az endometrialis sarcoma nem tartoznak ide.
- Korábbi kezelés
- Kapnia kellett platinaalapú kemoterápiát és PD(L)-1-gátlót, külön vagy együtt, 1-3 korábbi kezelési vonalban. Nem kaphatott korábban topoizomeráz 1-gátlót tartalmazó antitest-gyógyszer konjugátumot.
A részvétel fő kizáró okai
- Korábbi topoizomeráz 1-gátlót tartalmazó antitest-gyógyszer konjugátum
- Másik jelenlegi vagy korábbi daganat, néhány alacsony kockázatú kivétellel
- Aktív agyi áttét vagy a gerincvelői folyadékot érintő daganatos agyhártyagyulladás
- Korábbi vagy jelenlegi bélelzáródás
Gépi kiolvasás: 2026. november 12.
Helyszínek itt: Kanada
- Arthur J E Child Cancer CompCalgary, KanadaRésztvevőt keres
- MUHC, GLEN siteMontreal, KanadaRésztvevőt keres
- BC Cancer - VancouverVancouver, KanadaRésztvevőt keres
Kérdések a vizsgálat csapatának
- Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
- Megtérítik az utazási költséget?
- Megtarthatom a saját orvosomat?
- Mi történik, ha ki akarok lépni?
Contact the study team: see the registry record → Contacts and Locations
Oldal nyomtatása az orvosomnakA vizsgálat adatai
- Ki végzi
- Genmab
- Azonosító
- NCT07166094
- A regiszteradat frissítve
- 2026. november 3.
- Eredeti leírás
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.A teljes eredeti leírásKevesebb
A Phase 3 Randomized, Open-label Study of Rinatabart Sesutecan (Rina-S) Versus Treatment of Investigator's Choice (IC) in Patients With Endometrial Cancer After Platinum-Based Chemotherapy and PD(L)-1 Therapy
The purpose of this study is to compare how well Rina-S (GEN1184) works compared to treatment of physician's choice (paclitaxel or doxorubicin) that are considered standard medical care for the treatment of recurrent or progressive endometrial cancer (EC) following prior therapy. There is an equal (50:50) chance of getting either Rina-S or a chemotherapy agent as treatment in this study.
The study duration will be approximately 3 years. The treatment duration will be different for every participant, but an average of 4 to 6 months is expected.
All participants will receive active drug; no one will be given placebo. Participation in the study will require visits to the study site(s).
Bevonási feltételek: Participants must have histologically or cytologically confirmed recurrent or progressive endometrial cancer (EC; any subtype excluding neuroendocrine tumors, carcinosarcoma, or endometrial sarcoma) following prior therapy; Participants must have received at least 1, but not more than 3, prior lines of therapy:; Participants must have received prior platinum-based chemotherapy and a programmed death (ligand)-1 (PD(L)-1) inhibitor, either separately or in combination; If the tumor recurred more than 12 months after completion of platinum-based chemotherapy, additional platinum-based chemotherapy must be administered for recurrent disease unless the participant is ineligible for further platinum-based chemotherapy, in which case the reason for ineligibility must be documented; Note: If Immunotherapy-based treatment is administered in the advanced/recurrent setting, then platinum rechallenge is not required, regardless of the duration of the platinum-free interval from prior platinum-based chemotherapy. In such cases, the reason for ineligibility for platinum-based chemotherapy must be documented; Prior induction plus maintenance is considered 1 line of therapy; Hormonal therapy alone (i.e., without chemotherapy) will not be counted as a separate line of therapy; Therapy changed due to toxicity in the absence of progression will be considered part of the same line of therapy (i.e., will not be counted independently as a separate line of therapy); Participants must have progressed radiographically on or after their most recent line of therapy.
Kizáró feltételek: Prior therapy with an antibody-drug conjugate containing a topoisomerase 1 inhibitor; Has a past or current malignancy other than the inclusion diagnosis before the planned first dose of study drug, or any evidence of residual disease from a previously diagnosed malignancy. Exceptions are malignancies with a negligible risk of metastasis or death (e.g., 5-year OS ≥90%), including, but not limited to, adequately treated cervical carcinoma of Stage 1B or less, noninvasive basal cell or squamous cell skin carcinoma, noninvasive superficial bladder cancer, ductal carcinoma in situ, or any past malignancy considered cured for ≥3 years (i.e., eligible participants must have complete response of ≥3 years duration); Known active central nervous system metastases or carcinomatous meningitis. Participants with previously treated brain metastases may participate provided they are clinically stable for at least 4 weeks prior to study entry after completion of brain metastasis treatment, they have no new or enlarging brain metastases, and are off corticosteroids and anticonvulsants prescribed for symptoms associated with brain metastases for at least 7 days prior to the planned first dose of study drug. Participants with suspected brain metastases at screening should undergo a computed tomography (CT)/magnetic resonance imaging (MRI) of the brain prior to study entry; Hospitalization or clinical symptoms due to gastrointestinal obstruction within the past or radiographic evidence of gastrointestinal obstruction at the time of screening. Enrollment of participants who currently require parenteral nutrition must be discussed with the study medical monitor to determine eligibility; Note: Other protocol-defined Inclusion and Exclusion criteria may apply.