assignment

Recruiting

Phase II Open-Label Evaluation of Sacituzumab Govitecan in Patients with Unresectable Locally Advanced or Metastatic Urothelial Carcinoma

Trial ID: 2023-508302-24-00
Protocol: IMMU-132-06
Sponsor: Gilead Sciences Inc.

Trial statistics

science

test molecules

location_city

research sites

public

countries

medical_information

disease

person_search

investigators

handshake

vendors

Diseases & Conditions

Transitional cell cancer of the renal pelvis and ureter

Objectives

The primary objective of this Phase II open-label study is to evaluate the **objective response rate (ORR)** based on blinded independent central review (BICR) using the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria in patients with unresectable locally advanced or metastatic urothelial cancer. This is clinically relevant as ORR is a critical measure of the efficacy of cancer treatments, indicating the proportion of patients with a significant reduction in tumor size. Additionally, progression-free survival (PFS) based on BICR by RECIST 1.1 criteria is assessed in Cohort 5, and the safety and tolerability of sacituzumab govitecan (SG) in combination with enfortumab vedotin (EV) and zimberelimab (ZIM) are evaluated in Cohort 7.

Secondary objectives include:

Cohorts 1 and 2: Duration of response (DOR), PFS, and overall survival (OS) based on central review by RECIST 1.1 criteria.
Cohort 3: DOR, clinical benefit rate (CBR), and PFS based on BICR by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1 and modified RECIST 1.1 for immune-based therapeutics (iRECIST) criteria; OS; safety and tolerability of SG in combination with pembrolizumab.
Cohort 4: DOR, CBR, and PFS based on BICR by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1 and iRECIST criteria; OS; safety and tolerability of SG in combination with cisplatin.
Cohort 5: OS; safety and tolerability of SG in combination with ZIM.
Cohort 6: DOR, CBR, and PFS based on central review by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator review by RECIST 1.1 criteria; OS; safety and tolerability of SG alone, in combination with ZIM, and in combination with ZIM and domvanalimab (DOM).
Cohort 7: ORR based on BICR by RECIST 1.1 criteria; DOR, CBR, and PFS based on investigator review and BICR by RECIST 1.1 criteria; ORR, DOR, CBR, and PFS based on investigator review by iRECIST criteria; OS.

Participants

The clinical trial involves a total of **203 participants** diagnosed with **locally advanced or metastatic urothelial cancer**. The study population includes both male and female subjects aged 18 years and older, with a specific age threshold of 19 years for participants from South Korea. Participants were selected based on their diagnosis of histologically confirmed urothelial cancer, with the requirement of having measurable disease as per RECIST 1.1 criteria. The trial includes individuals who are cisplatin-ineligible and those who have not received prior systemic therapy for metastatic or unresectable locally advanced disease. Participants are required to have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1, indicating they are fully active or restricted in physically strenuous activity but ambulatory. The trial population is characterized by adequate hematologic and hepatic function, and a creatinine clearance of at least 30 mL/min. Lifestyle considerations such as diet and physical activity are not specified in the available data. The study includes a vulnerable population, and both male and female subjects of childbearing potential are required to use protocol-specified contraception methods. The sponsor has not provided additional information regarding specific lifestyle factors or habits of the participants.

Plans and Procedures

The clinical trial is designed to evaluate the efficacy and safety of **sacituzumab govitecan** in patients with unresectable locally advanced or metastatic urothelial cancer. This is a Phase II, open-label study, which means that both the researchers and participants know which treatment is being administered. The trial is expected to run from June 2019 to April 2025, with the primary objective being the assessment of the objective response rate (ORR) based on blinded independent central review (BICR) using RECIST 1.1 criteria. Secondary endpoints include duration of response (DOR), progression-free survival (PFS), and overall survival (OS), evaluated through both central and investigator assessments.

Participants will undergo a series of study visits, beginning with a screening visit to determine eligibility based on specific inclusion criteria, such as age, creatinine clearance, and prior treatment history. The trial includes multiple cohorts, each with distinct eligibility requirements and treatment regimens. For instance, Cohort 6 includes cisplatin-ineligible patients who have not received prior therapy for metastatic disease. The study involves regular follow-up visits to monitor the participants' health status, response to treatment, and any adverse effects. These visits are crucial for collecting data on the primary and secondary endpoints.

The expected duration of participant involvement varies depending on the cohort and treatment response, but the maximum treatment period is generally six months, with some exceptions extending up to 28 months. Participants may be withdrawn from the study early if they experience unacceptable toxicity, disease progression, or if they choose to withdraw consent. The end-of-study visit will occur after the completion of the treatment regimen or upon early termination, during which final assessments will be conducted to evaluate the overall outcomes of the trial.

Treatment

The clinical trial involves the administration of several experimental medications, each with specific pharmaceutical forms, dosages, and administration routes. **Cisplatin** is provided as a 1 mg/mL concentrate for solution for infusion. It is administered intravenously with a maximum daily dose of 70 mg/m². The treatment period for cisplatin is up to 6 cycles, with each cycle lasting 2 weeks. Participant compliance is monitored through regular assessments of infusion records and dosage calculations.

**Carboplatin** is administered as a 10 mg/mL solution for infusion. The route of administration is intravenous infusion, with a maximum daily dose of 4.5 mg/mL and a total dose of 5 mg/mL. The treatment period is also up to 6 cycles, each lasting 2 weeks. Compliance is ensured by tracking infusion schedules and dosage adherence.

**Gemcitabine** is provided as a 100 mg/mL concentrate for solution for infusion, administered intravenously. The maximum daily dose is 1000 mg/m², with a treatment period of up to 6 cycles, each cycle lasting 2 weeks. Compliance is monitored through infusion logs and dosage verification.

**Pembrolizumab** is available as a 25 mg/mL concentrate for solution for infusion, administered intravenously. The maximum daily dose is 200 mg, with a treatment period of up to 24 cycles, each cycle lasting 3 weeks. Participant compliance is tracked through infusion records and dosage checks.

**Enfortumab vedotin** is administered as a 30 mg powder for concentrate for solution for infusion, with intravenous infusion as the route of administration. The maximum daily dose is 125 mg, with a treatment period of up to 28 cycles, each cycle lasting 1 week. Compliance is monitored through infusion documentation and dosage accuracy.

**Zimberelimab** is provided as a concentrate for solution for infusion, administered intravenously. The maximum daily dose is 360 mg, with a treatment period of up to 6 cycles, each cycle lasting 2 weeks. Compliance is ensured by tracking infusion schedules and dosage adherence.

**Avelumab** is available as a 20 mg/mL concentrate for solution for infusion, administered via intravenous infusion. The maximum daily dose is 800 mg, with a treatment period of up to 6 cycles, each cycle lasting 2 weeks. Compliance is monitored through infusion logs and dosage verification.

**Domvanalimab** is administered as a concentrate for solution for infusion, with intravenous use as the route of administration. The maximum daily dose is 1200 mg, with a treatment period of up to 6 cycles, each cycle lasting 2 weeks. Compliance is tracked through infusion records and dosage checks.

**Sacituzumab govitecan** is provided as a 200 mg powder for concentrate for solution for infusion, administered intravenously. The maximum daily dose is 10 mg/kg, with a treatment period of up to 6 cycles, each cycle lasting 2 weeks. Compliance is ensured by tracking infusion schedules and dosage adherence.

Efficacy

The efficacy of the clinical trial will be assessed using several primary and secondary endpoints. The primary endpoint for Cohorts 1 to 4 is the **Objective Response Rate (ORR)** based on central review for Cohorts 1 and 2, and Blinded Independent Central Review (BICR) for Cohorts 3 and 4, as assessed by the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria. For Cohort 5, the primary endpoint is **Progression-Free Survival (PFS)** based on BICR, also assessed by RECIST 1.1 criteria. In Cohort 6, the primary endpoint is ORR based on BICR, and for Cohort 7, the primary efficacy endpoint is confirmed ORR based on investigator review, both assessed by RECIST 1.1 criteria.

Secondary efficacy endpoints vary across cohorts. For Cohorts 1 and 2, they include Duration of Response (DOR), PFS based on central review, and Overall Survival (OS). For Cohorts 3 and 4, secondary endpoints include DOR, Clinical Benefit Rate (CBR), and PFS based on BICR, as well as ORR, DOR, CBR, and PFS based on investigator assessment by RECIST 1.1 criteria and OS. In Cohort 5, the secondary endpoint is OS. Cohort 6's secondary endpoints include DOR, CBR, and PFS based on BICR, and ORR, DOR, CBR, and PFS based on investigator assessment by RECIST 1.1 criteria, with evaluations also according to iRECIST criteria. In Cohort 7, secondary endpoints include ORR based on BICR, DOR, CBR, and PFS based on both investigator review and BICR by RECIST 1.1 criteria, and OS, with additional evaluations by the investigator according to iRECIST criteria.

Inclusion and Exclusion Criteria

check_circle

Inclusion Criteria

Inclusion Criteria for Cohorts 1 to 6: Female or male individuals, ≥ 18 years of age (19 Years old for South Korea).
Individuals with histologically confirmed urothelial cancer (UC).
Eastern Cooperative Oncology Group (ECOG) Performance status score of 0 or 1.
Cohort 1: Have had progression or recurrence of urothelial cancer following receipt of platinum-containing regimen (cisplatin or carboplatin): Received a first-line platinum-containing regimen in the metastatic setting or for inoperable locally advanced disease; Or received neo/adjuvant platinum-containing therapy for localized muscle-invasive urothelial cancer, with recurrence/progression ≤12 months following completion of therapy.
Cohort 1: In addition to above criterion, have had progression or recurrence of urothelial cancer following receipt of an Anti-programmed Cell Death Protein 1 (anti-PD-1)/ Anti-programmed Death Ligand 1 (PD-L1) therapy.
Cohort 2: Were ineligible for platinum-based therapy for first line metastatic disease and have had progression or recurrence of urothelial cancer after a first-line therapy for metastatic disease with anti-PD-1/PD-L1 therapy. Individual may not have received any platinum for treatment of recurrent, metastatic or advanced disease.
Cohort 3: Progression or recurrence of UC following a platinum containing regimen in the metastatic setting, or progression or recurrence of UC within 12 months of completion of platinum-based therapy as neoadjuvant or adjuvant therapy.
Cohort 4: Individual has not received any platinum-based chemotherapy in the metastatic or unresectable locally advanced setting. Creatinine clearance of at least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For individuals receiving cisplatin at 70 mg/m^2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft -Gault formula or another validated tool is required. Individuals with creatinine clearance between 50 to 59 mL/min are to receive a split dose of cisplatin (35 mg/m^2 Day 1 and Day 8 of every 21-day cycle).
Cohorts 4, 5, 6: Archival tumor tissue comprising muscle-invasive or metastatic urothelial carcinoma, or a biopsy of metastatic urothelial carcinoma. Cohort 5: Individuals received at least 4 cycles and no more than 6 cycles of GEM + cisplatin. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after > 12 months from completion of therapy. No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST v1.1 guidelines as per investigator). Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.
Cohort 6: Cis-ineligible and no prior therapy for metastatic disease or for unresectable locally advanced disease. Checkpoint inhibitor therapy naïve or >12 months from completion of adjuvant therapy are permitted.
Cohorts 4 and 6: Have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Cohorts 1, 2, 3 and 5: Creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified
Cohort 6: cisplatin-ineligibility defined as meeting 1 of the following criteria: a) Creatinine clearance ≥ 30 mL/min to < 60 mL/min as assessed by the Cockcroft-Gault equation or other validated instruments (eg, Modification of Diet in Renal Disease equation) b) Grade ≥ 2 audiometric hearing loss c) Grade ≥ 2 peripheral neuropathy d) NYHA Class III heart failure
Cohort 6: checkpoint inhibitor therapy naive or > 12 months from completion of adjuvant therapy are permitted.
Cohorts 4, 5, and 6: adequate hematology without transfusion support or growth factor support within 2 weeks of study drug initiation ANC ≥ 1500 per mm3, platelets ≥ 100,000 per μL, and hemoglobin ≥ 9 g/dL).
Adequate hepatic function (bilirubin ≤ 1.5 ULN, AST and ALT ≤ 2.5  ULN or AST and ALT ≤ 5  ULN if known liver metastases).
Cohorts 1, 2, 3, and 5: creatinine clearance ≥ 30 mL/min as calculated by the Cockcroft-Gault formula unless otherwise specified.
Cohort 4: creatinine clearance of at least 50 mL/min calculated by Cockcroft-Gault formula or another validated tool. For subjects receiving cisplatin at 70 mg/m2 on Day 1 of every 21-day cycle, a creatinine clearance of least 60 mL/min calculated by Cockcroft-Gault formula or another validated tool is required. Subjects with creatinine clearance between 50 to 59 mL/min are to receive a split dose of cisplatin (35 mg/m2 Day 1 and Day 8 of every 21-day cycle).
Cohort 5: subjects received at least 4 cycles and no more than 6 cycles of GEM + cisplatin. No other chemotherapy regimens are allowed in this cohort, with the exception of prior adjuvant or neoadjuvant systemic therapy with curative intent after > 12 months from completion of therapy. a) No evidence of progressive disease following completion of first-line chemotherapy (ie, CR, PR, or SD per RECIST 1.1 guidelines as per investigator). b) Treatment-free interval of 4 to 10 weeks since the last dose of chemotherapy.
Subjects must have a 3-month life expectancy.
Adequate coagulation (prothrombin time [PT]) or international normalized ratio [INR] and activated partial thromboplastin time [aPTT]) ≤ 1.5  ULN unless subject is receiving anticoagulant therapy as long as PT or partial thromboplastin time (PTT) is within therapeutic range of intended use of anticoagulants.
Cohorts 4 and 6: have measurable disease by CT or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Male/assigned male at birth subjects and female/assigned female at birth subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocol-specified method(s) of contraception as described in Appendix 16.7.
Subject must be willing and able to comply with all protocol requirements.
Inclusion Criteria for Cohort 7: Female/assigned female at birth or male/assigned male at birth subjects, 18 years of age or older, able to understand and give written informed consent.
Subjects with histologically documented UC that is locally advanced (tumor [T] 4b, any node [N]; or any T, N 2-3) or metastatic (M1, Stage IV). Upper and lower tract tumors are permitted and mixed histologies are permitted if UC is the predominant histology.
Archival tumor tissue comprising primary or locally advanced or metastatic UC must be provided for biomarker testing including PD-L1 and Trop-2. If archival tumor tissue is not available, a fresh biopsy from locally advanced or metastatic UC must be provided for biomarker testing including PD-L1 and Trop-2.
No prior systemic therapy for locally advanced or metastatic UC. Therapy in the curative setting is allowed provided recurrence is > 12 months since the last dose of systemic therapy.
ECOG performance status 0-1.
Adequate hematologic counts without transfusional or growth factor support within 2 weeks of study drug initiation (hemoglobin ≥ 9 g/dL, ANC ≥ 1500/mm3, and platelets ≥ 100,000/μL).
Adequate hepatic function (bilirubin ≤ 1.5 × ULN, AST and ALT ≤ 2.5 × ULN or AST and ALT ≤ 5 × ULN if known liver metastases).
Creatinine clearance ≥ 30 mL/min as assessed by the Cockcroft-Gault equation or other validated instruments (eg, Modification of Diet in Renal Disease equation).
Have measurable disease by computed tomography (CT) or MRI as per RECIST 1.1 criteria. Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.
Subjects must have at least a 3-month life expectancy.
Male/assigned male at birth subjects and female/assigned female at birth subjects of childbearing potential who engage in heterosexual intercourse must agree to use protocolspecified method(s) of contraception as described in Appendix 16.7.
Subject must be willing and able to comply with all protocol requirements.

cancel

Exclusion Criteria

Exclusion Criteria for Cohorts 1 to 6: Females who are pregnant or lactating.
Is currently participating in or has participated in a study of an investigational agent or using an investigational device within 4 weeks prior to the first dose of study treatment.
Has a diagnosis of immunodeficiency.
Has had a prior anticancer mAb within 4 weeks prior to study Day 1 or who has not recovered (ie, Grade ≤ 1) from AEs due to agents administered more than 4 weeks earlier.
Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (ie, Grade ≤ 1 from AEs due to a previously administered agent). However, for Cohort 5: alopecia, sensory neuropathy Grade ≤ 2 is acceptable, or other Grade ≤ 2 adverse events not constituting a safety risk based on the investigator’s judgment are acceptable. Note: subjects with Grade ≤ 2 neuropathy or Grade ≤ 2 alopecia are an exception to this criterion and may qualify for the study. Note: if subject received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Cohort 4: refractory to platinum (ie, relapsed ≤ 12 months after completion of chemotherapy) in the neoadjuvant/adjuvant setting.
Criterion removed: requires concomitant medications that significantly interfere with UGT1A1 with no alternate option available.
Subjects with Gilbert’s disease.
Subjects who previously received irinotecan.
Has an active second malignancy. Note: subjects with a history of malignancy that has been completely treated, with no evidence of active cancer for 3 years prior to enrollment, or subjects with surgically cured tumors with low risk of recurrence are allowed to enroll.
Has known active central nervous system (CNS) metastases and/or carcinomatous meningitis. Subjects with previously treated brain metastases may participate provided they have stable CNS disease for at least 4 weeks prior to the first dose of study drug and all neurologic symptoms have returned to baseline), have no evidence of new or enlarging brain metastases, and are not using steroids ≥ 10 mg of prednisone (or equivalent) daily for brain metastases for at least 7 days prior to study treatment. All subjects with carcinomatous meningitis are excluded regardless of clinical stability.
Has active cardiac disease, defined as: a) Myocardial infarction or unstable angina pectoris within 6 months of the first date of study therapy. b) History of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias requiring antiarrhythmic medications (except for atrial fibrillation that is well controlled with antiarrhythmic medication); history of QT interval prolongation. c) NYHA Class III or greater congestive heart failure or left ventricular ejection fraction of < 40%.
Has active chronic inflammatory bowel disease (ulcerative colitis, Crohn’s disease) and subjects with a history of bowel obstruction.
Has prior history of clinically significant bleeding, intestinal obstruction, or GI perforation within 6 months of enrollment.
Must be at least 2 weeks beyond high-dose systemic corticosteroids (however, low-dose corticosteroids < 10 mg prednisone or equivalent daily are permitted for reasons outside of CNS disease provided the dose is stable for 4 weeks).
Has an active infection requiring systemic therapy.
Have known history of HIV-1 or -2 with uncontrolled viral load (ie, ≥ 200 copies/mL or CD4+ T-cell count < 350 cells/μL) or taking medications that may interfere with metabolism of study drugs. No HIV testing is required unless mandated by local health authority.
Has active hepatitis B virus or hepatitis C virus defined as those with a detectable viral load.
Has other concurrent medical or psychiatric conditions that, in the investigator’s opinion, may be likely to confound study interpretation or prevent completion of study procedures and follow-up examinations.
Use of live attenuated vaccine(s) within 30 days before start of study drug.
Cohorts 3, 4, 5, and 6: has an active autoimmune disease that required systemic treatment in past 2 years (ie, with use of disease-modifying agents, corticosteroids, or immunosuppressive drugs). Replacement therapy (eg, thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
Cohorts 3, 4, 5, and 6: has received a live vaccine including COVID-19 vaccines within 30 days prior to the first dose of study drug(s). Seasonal flu and COVID-19 vaccines that do not contain live virus are permitted.
Cohorts 3, 4, 5, and 6: has received immunosuppressive therapy within 3 years prior to Cycle 1 Day 1 (C1D1).
Cohorts 3, 4, 5, and 6: has history or evidence of interstitial lung disease or noninfectious pneumonitis.
Cohort 3: has received anti–PD-1– or anti–PD-L1–based therapy previously. Cohorts 4, 5, and 6: for subjects who received prior CPI, a treatment-free interval > 12 months between the last treatment administration and the date of recurrence is required.
Cohort 4 and Cohort 6: hypersensitivity or anaphylaxis to cisplatin, CARBO, or GEM.
Cohorts 1 to 6: have inability to tolerate or are allergic to SG, or CPIs, or are unable or unwilling to receive the doses specified in the protocol.
Cohort 4: Grade ≥ 2 hearing loss.
Cohort 4: Grade ≥ 2 peripheral neuropathy.
Cohort 5: subjects whose disease progressed by RECIST 1.1 on or after first-line chemotherapy for UC.
Exclusion Criteria for Cohort 7

Trial Status by Country

Country	Status	Start of Recruitment	Planned Patients
France	Recruiting	13 Jun 2019	65
Germany	Recruiting	13 Jun 2019	2
Greece	Recruiting	13 Jun 2019	3
Italy	Recruiting	13 Jun 2019	30
Spain	Recruiting	13 Jun 2019	16

Sites & Investigators

Research sites

Centre Hospitalier Regional Universitaire Institut De Cancerologie De Lorraine Ioannou Private Clinic-Private Polyclinics S.A.Centrum für Hämatologie und Onkologie am Bethanien-Krankenhaus

Investigators

Alexander F.Annalisa G.Stergios B.Gwenaelle G.

Investigational Products

Details about the medicinal products being studied in this clinical trial.

Product Name	Role in Trial	Formulation	Administration	Max Daily Dose	Treatment Duration	EU MP Number
Gemcitabine Accord 100 mg/ml koncentratas infuziniam tirpalui	Other	KONCENTRATAS INFUZINIAM TIRPALUI	INTRAVENOUS	1000	6	PRD10050563
Cisplatin 1 mg/ml Concentrate for Solution for Infusion	Other	CONCENTRATE FOR SOLUTION FOR INFUSION	INTRAVENOUS	70	6	PRD1168083
Padcev 30 mg powder for concentrate for solution for infusion	Test	POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION	INTRAVENOUS INFUSION	125	28	PRD9634494
Zimberelimab	Test	CONCENTRATE FOR SOLUTION FOR INFUSION	INTRAVENOUS	360	6	PRD9450049
CARBOPLATINE MEDAC 10 mg/mL, solution à diluer pour perfusion	Other	SOLUTION À DILUER POUR PERFUSION	INTRAVENIOUS INFUSION	4.5	6	PRD10027338
DOMVANALIMAB	Test	CONCENTRATE FOR SOLUTION FOR INFUSION	INTRAVENOUS USE	1200	6	PRD9450051
KEYTRUDA 25 mg/mL concentrate for solution for infusion	Other	CONCENTRATE FOR SOLUTION FOR INFUSION	INTRAVENOUS	200	24	PRD4323105
Bavencio 20 mg/mL concentrate for solution for infusion	Comparator	CONCENTRATE FOR SOLUTION FOR INFUSION	INTRAVENIOUS INFUSION	800	6	PRD5432331
Trodelvy 200 mg powder for concentrate for solution for infusion	Test	POWDER FOR CONCENTRATE FOR SOLUTION FOR INFUSION	INTRAVENOUS	10	6	PRD9351384

Also investigated for

Transitional cell carcinoma 5 Neoplasm 4 Colorectal cancer 3 Squamous cell carcinoma of head and neck 3