GEN1046 in Combination With Anticancer Agents for the Treatment of Advanced Endometrial Cancer
- Conditions
- Advanced Endometrial CancerMedDRA version: 21.0Level: PTClassification code: 10014733Term: Endometrial cancer Class: 100000004864Therapeutic area: Diseases [C] - Neoplasms [C04]
- Registration Number
- CTIS2022-502453-33-00
- Lead Sponsor
- Genmab A/S
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 78
Have a histologically confirmed diagnosis of advanced (unresectable, recurrent, and/or metastatic) endometrial carcinoma that is incurable and for which prior standard first-line treatment has failed., Prior to C1D1, documentation of tumor dMMR/MSI-H status must be available based on previously performed mismatch repair (MMR)/microsatellite instability (MSI) testing results using immunohistochemistry (IHC), polymerase chain reaction (PCR), or next-generation sequencing (NGS) performed with a Food and Drug Administration (FDA)-approved/Conformitè Europëenne (CE)-marked test., Must have progressed on or after at least 1 (but no more than 2) prior line(s) of a systemic chemotherapy regimen for unresectable and/or metastatic endometrial cancer of which at least 1 regimen of platinum-based treatment unless subject is ineligible for or intolerant to platinum., Cohort A only: Must be treatment naive for CPIs including PD-1 or PD-L1 inhibitors and other immune CPIs (eg, anticytotoxic T-lymphocyte-associated protein 4 [CTLA-4], anti-lymphocyte-activation gene 3 [LAG3], anti-T-cell immunoreceptor with immunoglobulin and immunoreceptor tyrosine-based inhibitory motif domains [TIGIT])., Cohort B only: Must have received and progressed on or after prior treatment with a PD-1/PD-L1 inhibitor alone or in combination. Moreover, the subject must fulfill the following:Duration of CPI containing treatment and best overall response (BOR) is known, and subject has received a minimum of 2 cycles of CPI.
Has carcinosarcoma, malignant mixed Mullerian tumor, endometrial leiomyosarcoma, or endometrial stromal sarcomas., Has been exposed to any of the following prior therapies/treatments within the specified timeframes: • Any prior treatment with any type of antitumor vaccine or autologous cell immunotherapy. • Radiotherapy within 14 days before the planned first dose of trial treatment with exception of palliative radiotherapy to bone lesions, which is allowed if completed 7 days prior to trial treatment start. Participants must have recovered from all radiation-related toxicities and/or complications prior to enrollment and must have tapered corticosteroid treatment to =10 mg/day at the time of first dose. • Treatment with an anticancer agent, including investigational vaccines within 28 days before or 5 times t1/2, whichever is shorter, prior to the planned first dose of trial treatment or is currently enrolled in an interventional trial. Note: Subjects who are in the follow-up phase of an interventional trial may participate if the subject has not received the investigational agent within 28 days of the first dose of trial treatment. • Prior treatment with live, attenuated vaccines within 30 days prior to initiation of trial treatment. Examples of live vaccines include, but are not limited to, the following: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, Bacillus Calmette–Guérin, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are allowed; however, intranasal influenza vaccines (eg, FluMist®) are live attenuated vaccines and are not allowed. Experimental and/or nonauthorized severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccinations are not allowed. • Received granulocyte colony-stimulating factor (G-CSF) or granulocyte-macrophage colony-stimulating factor (GM-CSF) support within 4 weeks before the planned first dose of trial treatment., Current pneumonitis (any grade) including any radiological change of ongoing pneumonitis at baseline or history of noninfectious drug-, immune-, or radiation-related pneumonitis that has required steroids., Cohort A only: Prior exposure to immune CPIs (eg, anti-PD-1/anti-PD-L1, anti-CTLA-4, anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell receptors (eg, 4-1BB, OX40), Cohort B only: • Known history of Grade 3 or higher irAEs that led to treatment discontinuation of a prior immunotherapy treatment • Exposure to any of the following prior therapies/treatments within the specified timeframes: • Prior exposure to immune CPIs other than anti-PD-1/anti-PD-L1 (eg, anti-CTLA-4, anti-LAG3, anti-TIGIT) or agents directed at costimulatory T-cell receptors (eg, 4-1BB, OX40) • PD-1/PD-L1 antibody within 28 days before the planned first dose of trial treatment
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method