Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2024
Sacituzumab Govitecan in Combination With Pembrolizumab for Patients With Metastatic Urothelial Cancer That Progressed After Platinum-Based Chemotherapy: TROPHY-U-01 Cohort 3.
Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 54 papers, 1 of them a synthesis that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase II Open-Label Study of Sacituzumab Govitecan in Unresectable Locally Advanced/Metastatic Urothelial Cancer
Bladder Preservation With Sacituzumab Govitecan + Zimberelimab for Muscle-Invasive Bladder Cancer in Cisplatin-unfit and Unwilling for Cystectomy Patients: Phase II Trial
Who cites it
54 citing papers in PubMed, 1 synthesis or guideline pooled it, 69 citations in OpenAlex.
- Antibody-drug conjugates and immune checkpoint inhibitors in cancer treatment: a systematic review and meta-analysis.Scientific reports · 2024Pooled it
- Atezolizumab monotherapy for metastatic urothelial carcinoma: final analysis from the phase II IMvigor210 trial.ESMO open · 2024Trial
- 68Ga-MY6349 PET/CT imaging to assess Trop2 expression in multiple types of cancer.The Journal of clinical investigation · 2024Trial
- TROPHY-U-01 Cohort 2: A Phase II Study of Sacituzumab Govitecan in Cisplatin-Ineligible Patients With Metastatic Urothelial Cancer Progressing After Previous Checkpoint Inhibitor Therapy.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Efficacy and Safety of Disitamab Vedotin in Patients With Human Epidermal Growth Factor Receptor 2-Positive Locally Advanced or Metastatic Urothelial Carcinoma: A Combined Analysis of Two Phase II Clinical Trials.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024Trial
- Exploring the immunological effects of antibody-drug conjugates.Nature reviews. Clinical oncology · 2026Review
- Clinical toxicity of ADCs and ICI-ADC combinations: mechanisms, patterns and management.Nature reviews. Clinical oncology · 2026Review
- Dermatologic adverse events associated with Sacituzumab Govitecan: an international retrospective study from the EADV Task Force "Dermatology for Cancer Patients" and pharmacovigilance analysis.Breast cancer research and treatment · 2026Article
- Quantitative Systems Pharmacology Model for TROP-2 Targeted Antibody-Drug Conjugate in Triple-Negative Breast Cancer.bioRxiv : the preprint server for biology · 2026Article
- Enfortumab vedotin induces immunogenic cell death and shows enhanced preclinical antitumor activity when combined with a PD-1 inhibitor.Cell reports. Medicine · 2026Article
- Review
- Coordinated Expression of ADC TargetsCurrent issues in molecular biology · 2026Article
- Combining antibody conjugates with cytotoxic and immune-stimulating payloads maximizes anti-cancer activity.Molecular oncology · 2026Article
- Sacituzumab govitecan combined with tislelizumab as second-line therapy for recurrent or metastatic cervical cancer: a case report and literature review.BMC women's health · 2026Review
- Immune checkpoint inhibitors in bladder cancer: from mechanistic insights to emerging combination frontlines.Clinical and experimental medicine · 2026Review
- Review
- Recent advances in immunotherapy for bladder cancer: mechanisms, clinical applications, and future perspectives.Frontiers in oncology · 2026Review
- Application of antibody-drug conjugates in locally advanced or metastatic urothelial carcinoma: mechanisms, treatment-related adverse events, and management strategies.Frontiers in pharmacology · 2026Review
- Strategic Combinations of Antibody-Drug Conjugates from 2023 to 2025: From Dual Therapies to Innovative ADC-Based Regimens.Pharmaceutics · 2025Review
- Overcoming resistance to antibody-drug conjugates: from mechanistic insights to cutting-edge strategies.Journal of hematology & oncology · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
20 authors at 14 institutions in 2 countries.
Funding
Abstract
purposePembrolizumab is standard therapy for patients with metastatic urothelial cancer (mUC) who progress after first-line platinum-based chemotherapy; however, only approximately 21% of patients respond. Sacituzumab govitecan (SG) is a trophoblast cell surface antigen-2-directed antibody-drug conjugate with US Food and Drug Administration-accelerated approval to treat patients with locally advanced or mUC who previously received platinum-based chemotherapy and a checkpoint inhibitor (CPI). Here, we report the primary analysis of TROPHY-U-01 cohort 3.
methodsTROPHY-U-01 (ClinicalTrials.gov identifier: NCT03547973) is a multicohort, open-label phase II study. Patients were CPI-naïve and had mUC progression after platinum-based chemotherapy in the metastatic setting or ≤12 months in the (neo)adjuvant setting. Patients received 10 mg/kg of SG once on days 1 and 8 and 200 mg of pembrolizumab once on day 1 of 21-day cycles. The primary end point was objective response rate (ORR) per central review. Secondary end points included clinical benefit rate (CBR), duration of response (DOR) and progression-free survival (PFS) per central review, and safety.
resultsCohort 3 included 41 patients (median age 67 years; 83% male; 78% visceral metastases [29% liver]). With a median follow-up of 14.8 months, the ORR was 41% (95% CI, 26.3 to 57.9; 20% complete response rate), CBR was 46% (95% CI, 30.7 to 62.6), median DOR was 11.1 months (95% CI, 4.8 to not estimable [NE]), and median PFS was 5.3 months (95% CI, 3.4 to 10.2). The median overall survival was 12.7 months (range, 10.7-NE). Grade ≥3 treatment-related adverse events occurred in 61% of patients; most common were neutropenia (37%), leukopenia (20%), and diarrhea (20%).
conclusionSG plus pembrolizumab demonstrated a high response rate with an overall manageable toxicity profile in patients with mUC who progressed after platinum-based chemotherapy. No new safety signals were detected. These data support further evaluation of SG plus CPI in mUC.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.