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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03745911
Other study ID # X31005
Secondary ID 2017-004486-27
Status Recruiting
Phase Phase 2
First received
Last updated
Start date May 4, 2018
Est. completion date November 2020

Study information

Verified date November 2018
Source Associació per a la Recerca Oncologica, Spain
Contact Joaquím Bellmunt, MD/PhD
Phone +34 932 483 860
Email jbellmunt@imim.cat
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Phase II Multicentre, single arm, open label study of Paclitaxel and TAK-228 in metastatic urothelial carcinoma (UC) and the impact of PI3K-mTOR pathway genomic alterations


Description:

The PI3K/AKT/mTOR pathway has been shown to be altered in a large percentage of metastatic urothelial carcinoma (UC) tumors. Within this pathway, the PI3 kinase alpha subunit (PIK3CA) is frequently mutated in muscle invasive bladder cancer (MIBC) (15-20%) and PTEN is inactivated in another 30%.

Due to TAK-228's effects on the PI3K/AKT/mTOR pathway in preclinical studies and the frequency of pathway alterations in UC tumors, TAK-228 is a rational therapy for bladder cancer.

This clinical investigation may also reveal how alterations in the PI3K/AKT/mTOR pathway correlate with treatment response. In preclinical bladder cell line models and xenografts done in our lab, synergistic effect has been seen with the combination with paclitaxel.

The primary end-point is objective response rate (ORR) with the goal of increasing the rate from 10% to 26%. Response rates will be measured using RECIST 1.1 criteria. PFS and OS will be measured from the start date of treatment with TAK-228 and paclitaxel. Grade 3, 4 or serious adverse events will be collected and compared to the catalogued events in the phase II trial in breast cancer (NCT01351350). Patient tumors will be analyzed for genetic alterations within the PI3K/AKT/mTOR pathway to determine if alterations within this pathway correlate with response rate, PFS, or OS.


Recruitment information / eligibility

Status Recruiting
Enrollment 52
Est. completion date November 2020
Est. primary completion date November 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

1. Male or female patients 18 years or older.

2. Patients must have a diagnosis of metastatic or advanced histologically confirmed UC (urothelial cancer). Mixed histologies are allowed.

3. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.

4. Female patients who:

- Are postmenopausal for at least 1 year before the screening visit, OR

- Are surgically sterile, OR

- If they are of childbearing potential, agree to practice 1 effective method of contraception and 1 additional effective (barrier) method, at the same time, from the time of signing the informed consent through 90 days (or longer as mandated by local labeling [e.g., USPI, SmPC, etc,]) after the last dose of study drug, OR

- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).

Male patients, even if surgically sterilized (i.e., status post-vasectomy), who:

- Agree to practice highly effective barrier contraception during the entire study treatment period and through 120 days after the last dose of study drug, OR

- Agree to practice true abstinence, when this is in line with the preferred and usual lifestyle of the patient. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods for the female partner], withdrawal, spermicides only, and lactational amenorrhea are not acceptable methods of contraception. Female and male condoms should not be used together).

- Agree not to donate sperm during the course of this study or within 120 days after receiving their last dose of study drug

5. Screening clinical laboratory values as specified below:

- Bone marrow reserve consistent with: absolute neutrophil count (ANC) = 1.5 x 109/L; platelet count = 100 x 109/L; hemoglobin = 9 g/dL without transfusion within 1 week preceding study drug administration.

- Hepatic: total bilirubin = 1.5 x upper limit of normal (ULN), transaminases (aspartate aminotransferase/serum glutamic oxaloacetic transaminase-AST/SGOT and alanine aminotransferase/serum glutamic pyruvic transaminase-ALT/SGPT) = 2.5 x ULN (= 5 x ULN if liver metastases are present);

- Renal: creatinine clearance =50 mL/min based either on Cockroft-Gault estimate or based on urine collection (12 or 24 hour);

- Metabolic: Glycosylated hemoglobin (HbA1c) <7.0%, fasting serum glucose (= 130 mg/dL) and fasting triglycerides = 300 mg/dL.

6. Ability to swallow oral medications.

7. Voluntary written consent must be given before performance of any study related procedure not part of standard medical care, with the understanding that consent may be withdrawn by the patient at any time without prejudice to future medical care.

8. Patients who have a history of brain metastasis are eligible for the study provided that all the following criteria are met:

- Brain metastases which have been treated.

- No evidence of disease progression for =3 months before the first dose of study drug.

- No hemorrhage after treatment.

- Off-treatment with dexamethasone for 4 weeks before administration of the first dose of TAK-228.

- No ongoing requirement for dexamethasone or anti-epileptic drugs.

9. Patients having received prior systemic chemotherapy treatment for UC, with no limit for number of prior systemic chemotherapeutic or investigational treatment regimens. Specifically, subjects must meet one or more of the following criteria:

• Progression after treatment with a regimen that includes a platinum salt (e.g. - carboplatin or cisplatin) for Stage IV disease.

OR

• Disease recurrence within one years from the date of last dose of chemotherapy or surgery until day the informed consent is signed) after neoadjuvant or adjuvant treatment with a regimen that includes a platinum salt.

10. Measurable disease, as defined by RECIST v.1.1. If all sites of measurable disease have been irradiated, one site must have demonstrated growth after irradiation.

11. Normal (or within 5% of lower limit) left ventricular ejection fraction

Exclusion Criteria:

1. Prior treatment with paclitaxel for UC (in any setting - neoadjuvant, adjuvant or for metastatic disease). Patients treated with prior docetaxel are eligible.

2. Previous treatment with PI3K, AKT, dual PI3K/mTOR inhibitors, TORC1/2 inhibitors or TORC1 inhibitors.

3. Manifestations of malabsorption due to prior gastrointestinal (GI) surgery, GI disease, or for an unknown reason that may alter the absorption of TAK-228. In addition, patients with enteric stomata are also excluded.

4. Poorly controlled diabetes mellitus defined as HbA1c > 7%; subjects with a history of transient glucose intolerance due to corticosteroid administration are allowed in this study if all other inclusion/exclusion criteria are met.

5. Presence of central nervous system metastasis, except for those matching requirements detailed per inclusion criterion 8.

6. Evidence of severe or uncontrolled systemic disease or any concurrent condition which in the Investigator's opinion makes it undesirable for the subject to participate in the trial or which would jeopardize compliance with the protocol.

7. History of any of the following within the last 6 months prior to study entry:

- Ischemic myocardial event, including angina requiring therapy and artery revascularization procedures

- Ischemic cerebrovascular event, including TIA and artery revascularization procedures

- Requirement for inotropic support (excluding digoxin) or serious (uncontrolled) cardiac arrhythmia (including atrial flutter/fibrillation, ventricular fibrillation or ventricular tachycardia)

- Placement of a pacemaker for control of rhythm

- New York Heart Association (NYHA) Class III or IV heart failure (See Appendix C)

- Pulmonary embolism.

8. Significant active cardiovascular or pulmonary disease at the time of study entry, including:

- Uncontrolled high blood pressure (i.e., systolic blood pressure >180 mm Hg, diastolic blood pressure > 95 mm Hg). Use of anti-hypertensive agents to control hypertension before Cycle 1 Day 1 is allowed.

- Pulmonary hypertension.

- Uncontrolled asthma or O2 saturation < 90% by ABG (Arterial Blood Gas) analysis or pulse oximetry on room air.

- Significant valvular disease; severe regurgitation or stenosis by imaging independent of symptom control with medical intervention, or history of valve replacement.

- Medically significant (symptomatic) bradycardia.

- History of arrhythmia requiring an implantable cardiac defibrillator.

- Baseline prolongation of the rate-corrected QT interval (QTc) (e.g., repeated demonstration of QTc interval > 480 milliseconds, or history of congenital long QT syndrome, or torsades de pointes).

9. History of arrhythmia (multifocal premature ventricular contractions (PVCs), bigeminy, trigeminy, ventricular tachycardia, or uncontrolled atrial fibrillation), which is symptomatic or requires treatment (CTCAE grade 3) or asymptomatic sustained ventricular tachycardia.

10. Controlled atrial fibrillation such as with medication or cardioversion is not excluded.

11. Treatment with systemic corticosteroids (either IV or oral steroids, excluding inhalers or low-dose hormone replacement therapy, i.e., prednisone =10mg or its equivalent) within 1 week before administration of the first dose of study drug.

12. Women who are currently pregnant or breast feeding.

13. Receipt of any investigational agent, chemotherapy or radiation therapy within 21 days prior to Study Day 1.

14. Any unresolved non-hematologic toxicity greater than CTCAE grade 1 from previous anti-cancer therapy (other than alopecia).

15. Major surgery within 4 weeks, or incompletely healed surgical incision before starting study therapy

16. Grade 2 or greater peripheral neuropathy

17. Diagnosed or treated for another malignancy within 2 years before administration of the first dose of study drug, or previously diagnosed with another malignancy and have any evidence of residual disease. Patients with non-melanoma skin cancer or carcinoma in situ of any type are not excluded if they have undergone complete resection.

18. Other clinically significant co-morbidities, such as uncontrolled pulmonary disease, active central nervous system disease, active infection, or any other condition that could compromise the patient's participation in the study.

19. Known human immunodeficiency virus infection

20. Known hepatitis B surface antigen-positive, or known or suspected active hepatitis C infection.

21. Any serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol

22. Patients who are taking proton pump inhibitors (PPIs) within 7 days of the first dose of study drug or who require treatment with PPIs throughout the trial or those who are taking H2 receptor antagonists within 24 hours of the first dose of study drug.

Study Design


Intervention

Combination Product:
Paclitaxel and TAK-228
Treatment with TAK-228 oral (D2, 3 and 4 of each week) and paclitaxel (D1 of each week) on Days 1, 8 and 15 for each 28-days cycle until disease progression or unacceptable toxicity. If paclitaxel is stopped, TAK-228 may be continued

Locations

Country Name City State
Spain Hospital de la Santa Creu i Sant Pau Barcelona
Spain Hospital del Mar Barcelona
Spain Hospital General Universitario de Elche Elche Alicante
Spain Clínica Universitaria de Navarra Pamplona Navarra
Spain Parc Taulí Hospital Universitario Sabadell Barcelona

Sponsors (3)

Lead Sponsor Collaborator
Associació per a la Recerca Oncologica, Spain Pivotal S.L., Takeda

Country where clinical trial is conducted

Spain, 

References & Publications (30)

Bajorin DF. Paclitaxel in the treatment of advanced urothelial cancer. Oncology (Williston Park). 2000 Jan;14(1):43-52, 57; discussion 58, 61-2. Review. — View Citation

Bowles DW, Diamond JR, Lam ET, Weekes CD, Astling DP, Anderson RT, Leong S, Gore L, Varella-Garcia M, Vogler BW, Keysar SB, Freas E, Aisner DL, Ren C, Tan AC, Wilhelm F, Maniar M, Eckhardt SG, Messersmith WA, Jimeno A. Phase I study of oral rigosertib (ON 01910.Na), a dual inhibitor of the PI3K and Plk1 pathways, in adult patients with advanced solid malignancies. Clin Cancer Res. 2014 Mar 15;20(6):1656-65. doi: 10.1158/1078-0432.CCR-13-2506. Epub 2014 Feb 3. — View Citation

Bowles DW, Ma WW, Senzer N, Brahmer JR, Adjei AA, Davies M, Lazar AJ, Vo A, Peterson S, Walker L, Hausman D, Rudin CM, Jimeno A. A multicenter phase 1 study of PX-866 in combination with docetaxel in patients with advanced solid tumours. Br J Cancer. 2013 Sep 3;109(5):1085-92. doi: 10.1038/bjc.2013.474. Epub 2013 Aug 13. — View Citation

Chiang GG, Abraham RT. Targeting the mTOR signaling network in cancer. Trends Mol Med. 2007 Oct;13(10):433-42. Epub 2007 Oct 1. Review. — View Citation

Ching CB, Hansel DE. Expanding therapeutic targets in bladder cancer: the PI3K/Akt/mTOR pathway. Lab Invest. 2010 Oct;90(10):1406-14. doi: 10.1038/labinvest.2010.133. Epub 2010 Jul 26. Review. — View Citation

Ghobrial IM, Siegel DS, Vij R, Berdeja JG, Richardson PG, Neuwirth R, Patel CG, Zohren F, Wolf JL. TAK-228 (formerly MLN0128), an investigational oral dual TORC1/2 inhibitor: A phase I dose escalation study in patients with relapsed or refractory multiple myeloma, non-Hodgkin lymphoma, or Waldenström's macroglobulinemia. Am J Hematol. 2016 Jun;91(4):400-5. doi: 10.1002/ajh.24300. — View Citation

Gomez-Pinillos A, Ferrari AC. mTOR signaling pathway and mTOR inhibitors in cancer therapy. Hematol Oncol Clin North Am. 2012 Jun;26(3):483-505, vii. doi: 10.1016/j.hoc.2012.02.014. Epub 2012 Mar 31. Review. — View Citation

Guo Y, Chekaluk Y, Zhang J, Du J, Gray NS, Wu CL, Kwiatkowski DJ. TSC1 involvement in bladder cancer: diverse effects and therapeutic implications. J Pathol. 2013 May;230(1):17-27. doi: 10.1002/path.4176. Epub 2013 Mar 21. — View Citation

Hassan B, Akcakanat A, Takafumi S, Evans K, Adkins F, Meric-Bernstam F. Inhibitor MLN0128 Has Antitumor Efficacy In Cell Lines With Intrinsic And Acquired Rapamycin-Resistance. Academic Surgical Congress 2013(Abstract ASC20130420).

Iyer G, Al-Ahmadie H, Schultz N, Hanrahan AJ, Ostrovnaya I, Balar AV, Kim PH, Lin O, Weinhold N, Sander C, Zabor EC, Janakiraman M, Garcia-Grossman IR, Heguy A, Viale A, Bochner BH, Reuter VE, Bajorin DF, Milowsky MI, Taylor BS, Solit DB. Prevalence and co-occurrence of actionable genomic alterations in high-grade bladder cancer. J Clin Oncol. 2013 Sep 1;31(25):3133-40. doi: 10.1200/JCO.2012.46.5740. Epub 2013 Jul 29. — View Citation

Jessen K, Wang S, Kessler L, et al. INK128 is a potent and selective TORC1/2 inhibitor with broad oral antitumor activity. Mol Cancer Ther. 2009;8(12 Suppl) Abstract B148

Kessler L, Wang S, Xin G, Kucharski J, Staunton J, Lan L, et al. INK128, an orally active TORC1/2 kinase inhibitor, shows broad antitumor activity and enhances efficacy of cytotoxic as well as targeted agents. Cancer Res 2010;70(8; Supplement 1 Abstract 4496).

Milowsky, M.I., Final results of a multicenter, open-label phase II trial of dovitinib (TKI258) in patients with advanced urothelial carcinoma with either mutated or nonmutated FGFR3. 2013, J Clin Oncol 2013; 31(Suppl 6) [abstract: 255].

Mondesire WH, Jian W, Zhang H, Ensor J, Hung MC, Mills GB, Meric-Bernstam F. Targeting mammalian target of rapamycin synergistically enhances chemotherapy-induced cytotoxicity in breast cancer cells. Clin Cancer Res. 2004 Oct 15;10(20):7031-42. — View Citation

Ortmann CA, Mazhar D. Second-line systemic therapy for metastatic urothelial carcinoma of the bladder. Future Oncol. 2013 Nov;9(11):1637-51. doi: 10.2217/fon.13.139. Review. — View Citation

PACLITAXEL - paclitaxel injection, solution [package insert]. Princeton, NJ. Sandoz; 2011

Platt FM, Hurst CD, Taylor CF, Gregory WM, Harnden P, Knowles MA. Spectrum of phosphatidylinositol 3-kinase pathway gene alterations in bladder cancer. Clin Cancer Res. 2009 Oct 1;15(19):6008-17. doi: 10.1158/1078-0432.CCR-09-0898. Epub 2009 Sep 29. — View Citation

Raghavan D. Progress in the chemotherapy of metastatic cancer of the urinary tract. Cancer. 2003 Apr 15;97(8 Suppl):2050-5. Review. — View Citation

Rossi JF. Phase I study of atacicept in relapsed/refractory multiple myeloma (MM) and Waldenström's macroglobulinemia. Clin Lymphoma Myeloma Leuk. 2011 Feb;11(1):136-8. doi: 10.3816/CLML.2011.n.031. — View Citation

Sabatini DM. mTOR and cancer: insights into a complex relationship. Nat Rev Cancer. 2006 Sep;6(9):729-34. Epub 2006 Aug 17. Review. — View Citation

Seront E, Rottey S, Sautois B, Kerger J, D'Hondt LA, Verschaeve V, Canon JL, Dopchie C, Vandenbulcke JM, Whenham N, Goeminne JC, Clausse M, Verhoeven D, Glorieux P, Branders S, Dupont P, Schoonjans J, Feron O, Machiels JP. Phase II study of everolimus in patients with locally advanced or metastatic transitional cell carcinoma of the urothelial tract: clinical activity, molecular response, and biomarkers. Ann Oncol. 2012 Oct;23(10):2663-70. Epub 2012 Apr 3. — View Citation

Shafer A, Zhou C, Gehrig PA, Boggess JF, Bae-Jump VL. Rapamycin potentiates the effects of paclitaxel in endometrial cancer cells through inhibition of cell proliferation and induction of apoptosis. Int J Cancer. 2010 Mar 1;126(5):1144-54. doi: 10.1002/ijc.24837. — View Citation

Shu CH, Yang WK, Shih YL, Kuo ML, Huang TS. Cell cycle G2/M arrest and activation of cyclin-dependent kinases associated with low-dose paclitaxel-induced sub-G1 apoptosis. Apoptosis. 1997;2(5):463-70. — View Citation

Siegel R, Naishadham D, Jemal A. Cancer statistics, 2013. CA Cancer J Clin. 2013 Jan;63(1):11-30. doi: 10.3322/caac.21166. Epub 2013 Jan 17. — View Citation

TAK-228 Investigator Brochure Edition 10. 22 March 2017

Vaughn DJ, Broome CM, Hussain M, Gutheil JC, Markowitz AB. Phase II trial of weekly paclitaxel in patients with previously treated advanced urothelial cancer. J Clin Oncol. 2002 Feb 15;20(4):937-40. — View Citation

Verdoorn BP, Kessler ER, Flaig TW. Targeted therapy in advanced urothelial carcinoma. Oncology (Williston Park). 2013 Mar;27(3):219-26. Review. — View Citation

von der Maase H, Sengelov L, Roberts JT, Ricci S, Dogliotti L, Oliver T, Moore MJ, Zimmermann A, Arning M. Long-term survival results of a randomized trial comparing gemcitabine plus cisplatin, with methotrexate, vinblastine, doxorubicin, plus cisplatin in patients with bladder cancer. J Clin Oncol. 2005 Jul 20;23(21):4602-8. — View Citation

Voss M, Gordon MS, Mita M, Rini B, Makker V, Macarulla T, et al. Phase I study of investigational oral mTORC1/2 inhibitor TAK-228 (formerly MLN0128): expansion phase in patients with renal, endometrial, or bladder cancer. ESMO poster Sept 2015

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* Note: There are 30 references in allClick here to view all references

Outcome

Type Measure Description Time frame Safety issue
Other Characterization of PI3K/ AKT/ mTOR pathway mutations Patient tumors samples will be analyzed for genetic alterations within the PI3K/AKT/mTOR pathway to determine if alterations within this pathway correlate with response rate, in patients with UC 34 months
Other Characterization of PI3K/ AKT/ mTOR pathway mutations Patient tumors samples will be analyzed for genetic alterations within the PI3K/AKT/mTOR pathway to determine if alterations within this pathway correlate with PFS, in patients with UC 34 months
Other Characterization of PI3K/ AKT/ mTOR pathway mutations Patient tumors samples will be analyzed for genetic alterations within the PI3K/AKT/mTOR pathway to determine if alterations within this pathway correlate with OS, in patients with UC 34 months
Other To discover biomarkers in the serum or plasma (pre and post treatment) of subjects that may predict response to therapy. Findings suggest S2481 phosphorylation could be a marker for activity of mTORC2. S2481 has the potential to be a prognostic, predictive, and pharmacodynamic marker:
• Characterize the phosphorylation of S2481 of mTOR in UC tumor tissue
34 months
Other To discover biomarkers in the serum or plasma (pre and post treatment) of subjects that may predict response to therapy. Findings suggest S2481 phosphorylation could be a marker for activity of mTORC2. S2481 has the potential to be a prognostic, predictive, and pharmacodynamic marker:
Evaluate whether basal levels of mTOR S2481 phosphorylation correlate with prognosis and/or are predictive of clinical outcomes of the study patients treated with the combination
34 months
Other To discover biomarkers in the serum or plasma (pre and post treatment) of subjects that may predict response to therapy. Findings suggest S2481 phosphorylation could be a marker for activity of mTORC2. S2481 has the potential to be a prognostic, predictive, and pharmacodynamic marker:
Assess for changes in tumoral phospho-S2481 after treatment in the biopsy subset of patients.
34 months
Primary Objective Response Rate (ORR) Objective response rate (ORR), defined as the sum of the complete and partial responses (CR+PR), with the goal of increasing the rate from 10% to 26%. Response rates will be measured using RECIST 1.1 criteria 34 months
Secondary Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] To assess the safety and evaluate the tolerability of TAK-228 in combination with paclitaxel in patients with metastatic, previously treated transitional cell carcinoma. 34 months
Secondary Progression-Free Survival (PFS) Time from the first day of therapy to the first evidence of progression as defined by RECIST, or death from any cause, whichever is first. Patients who die without a reported prior progression will be considered to have progressed on the day of their death. Patients alive and without disease progression will be censored at the time of the last objective tumor assessment. Patients who do not progress and are subsequently lost to follow-up will have their data censored at the day of their last objective tumor assessment. 34 months
Secondary Overall Survival (OS) Time from the first day of therapy to the date of death from any cause. If the patient is alive at the end of the follow-up period or is lost to follow-up, OS will be censored on the last date the patient is known to be alive. 34 months
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Completed NCT02826564 - Trial of Stereotactic Body Radiotherapy With Concurrent Pembrolizumab in Metastatic Urothelial Cancer Phase 1
Completed NCT01963052 - ASG-15ME is a Study of Escalating Doses of AGS15E Given as Monotherapy in Subjects With Metastatic Urothelial Cancer Phase 1
Not yet recruiting NCT05390645 - A Study of MFA-370 in Patients With Metastatic Urothelial Cancer Phase 1/Phase 2
Completed NCT03390595 - Avelumab Plus Carboplatin-gemcitabine in Urothelial Carcinoma Phase 2
Completed NCT03451331 - Gemcitabine + Carboplatin + Nivolumab Versus Gemcitabine + Oxaliplatin + Nivolumab in Cisplatin-ineligible Patients With Metastatic Urothelial Cancer Phase 2
Active, not recruiting NCT04995419 - A Study to Evaluate Enfortumab Vedotin (ASG-22CE) in Chinese Participants With Locally Advanced or Metastatic Urothelial Cancer Who Previously Received Platinum-containing Chemotherapy and Programmed Cell Death Protein-1 ( PD 1) / (Programmed Death Ligand-1 (PD-L1) Inhibitor Therapy Phase 2
Completed NCT03679767 - A Study of INCMGA00012 in Participants With Selected Solid Tumors (POD1UM-203) Phase 2
Recruiting NCT06225596 - Study BT8009-230 in Participants With Locally Advanced or Metastatic Urothelial Cancer (Duravelo-2) Phase 2/Phase 3
Completed NCT02240017 - A Study Evaluating Chemotherapy With Fractionated Cisplatin/Gemcitabine Versus Carboplatin/Gemcitabine in the Treatment of Advanced or Metastatic Urothelial Cancer With Impaired Renal Function. Phase 2/Phase 3
Recruiting NCT03547973 - Study of Sacituzumab Govitecan in Participants With Urothelial Cancer That Cannot Be Removed or Has Spread Phase 2
Completed NCT03070990 - A Study of Enfortumab Vedotin in Japanese Subjects With Locally Advanced or Metastatic Urothelial Carcinoma Phase 1
Completed NCT03448718 - Trial of Olaparib in Patients With Metastatic Urothelial Cancer Harboring DNA Damage Response Gene Alterations Phase 2

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