⭐️⭐️⭐️⭐️⭐️ "A total no brainer"

⭐️⭐️⭐️⭐️⭐️ "Love this, so easy."

Spots is the easy way to track your skin, mole and cancer changes.

Spots Global Cancer Trial Database for PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer

The following info and data is provided "as is" to help patients around the globe.
We do not endorse or review these studies in any way.

Trial Identification

Brief Title: PeRioperative Immunotherapy Combined With Sacituzumab Govitecan in Muscle Invasive blAdder Cancer

Official Title: An Open Label, Single-arm, Phase 2 Study of Perioperative Sacituzumab Govitecan in Combination With Zimberelimab and Domvanalimab for Patients With Muscle Invasive Bladder Cancer Ineligible for Cisplatin-based Chemotherapy

Study ID: NCT06133517

Study Description

Brief Summary: The main objective of this trial is to evaluate the efficacy of the combo Sacituzumab govitecan (SG) + Zimberelimab (AB 122) (ZIM) + Domvanalimab (AB 154) (DOM), measured as pathologic complete response (pCR) rates, in the perioperative setting in patients with Muscle Invasive Bladder Cancer (MIBC) who are either unfit for platinum-based chemotherapy or unwilling to receive that therapy.

Detailed Description: This is an open label, multicenter, single arm, phase II clinical trial, which aims to evaluate the effects of perioperative treatment with sacituzumab govitecan, zimberelimab and domvanalimab in patients with confirmed histological diagnosis of urothelial bladder carcinoma pT2-T4a cN0-1 cM0 non-eligible or who refuse to receive cisplatin-based neoadjuvant chemotherapy. Patients who are eligible to participate in the study will receive 3 cycles of sacituzumab govitecan, zimberelimab and domvanalimab every 3 weeks prior to cystectomy, unless there are signs of unacceptable toxicity, progressive disease or the patient requests withdrawal from the study. Patients who do not achieve a pCR or that achieving a pCR still have positive ctDNA will also complete an adjuvant phase of the study consisting of 12 additional cycles of zimberelimab and domvanalimab. To progressively test the safety of the proposed combination, this study has been developed in two stages with the aim of preserving patient's safety as a priority. This study includes a preliminary assessment about the safety of the combinations. Thus, there will be a safety run-in period in which 8 patients will receive the SG+ZIM combination to confirm the tolerability of this doublet in patients with MIBC. Once the safety of this doublet has been confirmed by an external safety committee then the study will proceed to an additional safety-run in cohort with the triplet.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

Hospital Clínico Universitario de Santiago, Santiago De Compostela, A Coruña, Spain

ICO Badalona, Badalona, Barcelona, Spain

Hospital Duran i Reynals (ICO L´Hospitalet), L'Hospitalet De Llobregat, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla, Santander, Cantabria, Spain

Hospital Universitario Donostia, Donostia, Gipuzkoa, Spain

Hospital Universitario de Navarra, Pamplona, Navarra, Spain

Hospital Clínico San Carlos, Madrid, , Spain

Hospital Virgen de la Salud, Toledo, , Spain

Fundación Instituto Valenciano de Oncología, Valencia, , Spain

Hospital Clinico Universitario de Valladolid, Valladolid, , Spain

Contact Details

Name: Ignacio Duran, MD

Affiliation: Hospital Universitario Marqués de Valdecilla

Role: PRINCIPAL_INVESTIGATOR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

Logo

Take Control of Your Skin and Body Changes Today.

Try out Spots for free, set up only takes 2 mins.

spots app storespots app store

Join others from around the world: