Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Respiratory Tract (Lung and Bronchial) Diseases

Skin and Connective Tissue Diseases

Digestive System Diseases

Gland and Hormone Related Diseases

Blood and Lymph Conditions

Rare Diseases

Uterine Cervical Neoplasms

Nasopharyngeal Carcinoma

Carcinoma

Small Cell Lung Carcinoma

Carcinoma, Neuroendocrine

Cholangiocarcinoma

Breast Neoplasms

Adenocarcinoma

Triple Negative Breast Neoplasms

Melanoma

Skin Neoplasms

Carcinoma, Non-Small-Cell Lung

Carcinoma, Transitional Cell

Prostatic Neoplasms

Stomach Neoplasms

Carcinoma, Squamous Cell

Squamous Cell Carcinoma of Head and Neck

Head and Neck Neoplasms

Carcinoma, Renal Cell

Lung Neoplasms

Carcinoma, Hepatocellular

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Vulvar Neoplasms

Liver Neoplasms

Carcinoma, Basal Cell

Mesothelioma

Mesothelioma, Malignant

Thymoma

Thymus Neoplasms

Anus Neoplasms

Colorectal Neoplasms

Endometrial Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Diseases

Neoplasms, Squamous Cell

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Cervical Diseases

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Nasopharyngeal Neoplasms

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Adenoma

Neoplasms, Mesothelial

Respiratory Tract Neoplasms

Thoracic Neoplasms

Pleural Neoplasms

Lung Diseases

Respiratory Tract Diseases

Breast Diseases

Neoplasms, Basal Cell

Intestinal Neoplasms

Colonic Diseases

Intestinal Diseases

Rectal Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Lymphatic Diseases

Rectal Neoplasms

Anus Diseases

Vulvar Diseases

Small Cell Lung Cancer

Ovarian Cancer

Transitional Cell Carcinoma

Bile Duct Cancer

Renal Cell Carcinoma

Stomach Cancer

Ovarian Epithelial Cancer

Clear Cell Renal Cell Carcinoma

Fallopian Tube Cancer

Malignant Mesothelioma

Penile Cancer

Anal Cancer

Vulvar Cancer

All Drugs and Chemicals

Antibodies

Antibodies, Bispecific

Immunoglobulins

XmAb20717 administered by intravenous dosing on Days 1 and 15 of each 28-day cycle for a total of two cycles

XmAb20717

Zequn Tang, MD

This is a Phase 1, multiple dose, ascending dose escalation study to define a MTD/RD and regimen of XmAb20717, to describe safety and tolerability, to assess PK and immunogenicity, and to preliminarily assess anti-tumor activity of XmAb20717 in subjects with selected advanced solid tumors.

A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

A Phase 1 Multiple Dose Study to Evaluate the Safety and Tolerability of XmAb®20717 in Subjects With Selected Advanced Solid Tumors

Treatment-related adverse events as assessed by CTCAE v4.03

ICON plc

Xencor, Inc.

Symptoms and General Pathology

Death

Carcinoma, Small Cell

Urinary Bladder Neoplasms

Carcinoma, Medullary

Penile Neoplasms

Thyroid Neoplasms

Thyroid Diseases

Urologic Neoplasms

Kidney Neoplasms

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Genital Neoplasms, Male

Genital Diseases, Male

Penile Diseases

Endocrine Gland Neoplasms

Endocrine System Diseases

Kidney Diseases

Thyroid Cancer, Medullary

Renal Medullary Carcinoma

Small Cell Carcinoma of the Bladder

Neuroendocrine Tumor

Neuroepithelioma

Antineoplastic Agents

Atezolizumab

Irinotecan

Sacituzumab govitecan

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Immunoconjugates

Immunologic Factors

Treatment with sacituzumab govitecan and atezolizumab

Sacituzumab govitecan is administered IV at 10 mg/kg on days 1 and 8 of each 21-day cycle.

Atezolizumab is administered IV at 1200 mg on day 1 each 21-day cycle.

Lisa Ley, R.N.

Andrea B Apolo, M.D.

Lisa Ley

Background:

Rare tumors of the genitourinary (GU) tract can appear in the kidney, bladder, ureters, and penis. Rare tumors are difficult to study because there are not enough people to conduct large trials for new treatments. Two drugs-sacituzumab govitecan (SG) and atezolizumab-are each approved to treat other cancers. Researchers want to find out if the two drugs used together can help people with GU.

Objective:

To test SG, either alone or combined with atezolizumab, in people with rare GU tumors.

Eligibility:

Adults aged 18 years and older with rare GU tumors. These may include small cell carcinoma of the bladder; squamous cell carcinoma of the bladder; primary adenocarcinoma of the bladder; renal medullary carcinoma; or squamous cell carcinoma of the penis.

Design:

Participants will be screened. They will have a physical exam with blood and urine tests. They will have tests of heart function. They will have imaging scans. They may need a biopsy: A small needle will be used to remove a sample of tissue from the tumor.

Both SG and atezolizumab are given through a tube attached to a needle inserted into a vein in the arm.

All participants will receive SG on days 1 and 8 of each 21-day treatment cycle. Some participants will also receive atezolizumab on day 1 of each cycle.

Blood and urine tests, imaging scans, and other exams will be repeated during study visits.

Treatment may continue for up to 5 years.

Follow-up visits will continue for 5 more years.

Background:

* Urothelial carcinoma (UC) represents the most common histology for tumors of the bladder and urinary tract.
* A minority of patients have primary tumors of the bladder/urinary tract consisting of rare histological variants, including small cell carcinoma, primary adenocarcinoma of the bladder (urachal or non-urachal), or squamous cell carcinoma. Some tumors may contain elements of UC mixed with these variants or may be entirely composed of such variants.
* Clear cell renal cell carcinoma (ccRCC) is the most common histology for cancers of the renal parenchyma. Renal medullary carcinoma is a rare histology of kidney cancer, which is associated with sickle cell trait and other hemoglobinopathies.
* Rare tumors of the genitourinary (GU) tract often have more aggressive clinical course, but lack standard of care treatment regimens, since these patient populations are poorly represented or excluded from most clinical trials.
* Sacituzumab govitecan (SG) is an antibody-drug conjugate of an IgG 1 monoclonal antibody targeting trophoblastic cell surface antigen 2 (Trop2) with a chemotherapeutic payload of SN-38. SN-38 is an active metabolite of irinotecan and acts as a topoisomerase I inhibitor.
* SG has demonstrated clinical activity in solid tumors. In phase II clinical trials, SG has demonstrated efficacy in metastatic UC after progression on platinum-based chemotherapy and immune checkpoint inhibitor (ICI) therapy.
* Atezolizumab is an anti- programmed death-ligand 1 (PD-L1) ICI that is approved for advanced/metastatic UC in patients ineligible to receive platinum therapy.
* There are currently no clinical trials for SG monotherapy or SG/atezolizumab combination in rare GU tumors.

Objective:

-To determine clinical efficacy of sacituzumab govitecan (SG), either alone or in combination with atezolizumab, as defined by objective response rate (ORR), in participants with rare metastatic non-prostate genitourinary tumors

Eligibility:

* Age \>= 18 years
* ECOG performance status \<= 1
* Histologically confirmed diagnosis of locally advanced (unresectable) or metastatic GU tumors of the following histologies: small cell carcinoma, squamous cell carcinoma, or primary adenocarcinoma of the bladder or urinary tract; or renal medullary carcinoma or squamous cell carcinoma of the penis.
* Participants must have locally advanced unresectable or metastatic disease on cross-sectional imaging.
* Participants may have received any prior programmed cell death protein 1 (PD-1)/PD-L1 axis ICI treatment.

Design:

* This is an open label, non-randomized phase II trial with two arms.
* All participants will receive SG.
* Participants without prior treatment with any PD-1/PD-L1 axis ICI (checkpoint inhibitor na(SqrRoot) ve) will be eligible to receive concurrent atezolizumab.
* SG will be administered intravenously (IV) at 10 mg/kg on D1 and D8 of 21-day cycles.
* Atezolizumab will be administered IV at 1200mg on D1 of 21-day cycles.
* Treatment will be given in 21-day cycles continuously for a maximum of 5 years, or until signs of progression or intolerable side effects.
* The accrual ceiling will be set at 60 to allow for inevaluable participants and screen failure.

Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer

A Phase II Study of Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer

Percentage of participants by best overall response (e.g., CR, PR, SD,PD) to therapy

Time from start of treatment to disease progression or death in participants who achieve CR or PR

Time from the start of treatment that participants are still alive.

Duration of time from start of treatment to time of progression or death, whichever occurs first

Percentage of participant who have achieved CR, PR, and SD while on treatment.

Adverse events (AEs) will be reported by type and grade of toxicity

National Cancer Institute (NCI)

Patients undergo data collection every 6 months for up to 15 years.

Data Capture

Questionnaire Administration

Curtis A. Pettaway

Curtis A Pettaway

This study develops a prospective database of patients who are evaluated and treated for penile cancer. This will facilitate analyzing trends in cancer incidence, risk factors, treatment, complications, and tumor progression. It will also prospectively validate the importance of pathological prognostic factors previously reported and outcome related to contemporary treatment.

PRIMARY OBJECTIVE:

I. To prospectively collect data on the presenting features, management and outcome of penile carcinoma at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, The Woodlands and Bay Area Regional Care Centers.

OUTLINE:

Patients undergo data collection every 6 months for up to 15 years.

Contemporary Characteristics of Penile Cancer

Contemporary Characteristics of Penile Carcinoma: at M.D. Anderson Cancer Center, and Harris Health System and Katy, Sugar Land, the Woodlands and Bay Area Regional Care Centers

Descriptive statistics will be utilized where applicable to address questions relevant to the study aims.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of XmAb®20717 in Subjects With Selected Advanced Solid Tumors	NCT03517488	Melanoma Breast Carcinom... Hepatocellular ... Urothelial Carc... Squamous Cell C... Renal Cell Carc... Colorectal Carc... Non-small Cell ... Gastric or Gast... Endometrial Car... Mesothelioma Neuroendocrine ... Cervical Cancer Small Cell Lung... Squamous Cell C... Castration-Resi... Nasopharyngeal ... Cholangiocarcin... Basal Cell Carc... Ovarian Carcino... Fallopian Tube ... Thymoma Thymic Carcinom... Squamous Cell C... Vulvar Carcinom... Solid Tumors Wi... Malignant Adnex... Non-squamous Ce...	XmAb20717	18 Years -	Xencor, Inc.
Sacituzumab Govitecan With or Without Atezolizumab Immunotherapy in Rare Genitourinary Tumors (SMART) Such as Small Cell, Adenocarcinoma, and Squamous Cell Bladder/Urinary Tract Cancer, Renal Medullary Carcinoma and Penile Cancer	NCT06161532	Small Cell Carc... Small Cell Carc... Squamous Cell C... Squamous Cell C... Primary Adenoca... Primary Adenoca... Renal Medullary... Squamous Cell C...	Sacituzumab gov... Atezolizumab	18 Years - 120 Years	National Institutes of Health Clinical Center (CC)
Contemporary Characteristics of Penile Cancer	NCT04996849	Penile Carcinom... Squamous Cell C...	Data Capture Questionnaire A...	-	M.D. Anderson Cancer Center
PEN-866 in Patients With Advanced Solid Malignancies	NCT03221400	Carcinoma Endometrial Ade... Neoplasms Squamous Cell C... Adenocarcinoma ... Advanced Cancer Solid Tumor Solid Carcinoma Squamous Cell C... Squamous Cell C... Squamous Cell C... Squamous Cell C... Gastric Cancer Gastric Adenoca... Gastroesophagea... Small-cell Lung... Small Cell Lung... Pancreatic Duct... Pancreatic Aden...	PEN-866 Sodium fluorouracil Folinic acid Niraparib	18 Years -	Tarveda Therapeutics
Contemporary Characteristics of Penile Cancer	NCT04996849	Penile Carcinom... Squamous Cell C...	Data Capture Questionnaire A...	-	M.D. Anderson Cancer Center
Efficacy and Safety of Cetuximab in Metastatic Penile Carcinoma (PENILANE)	NCT02014831	Squamous Cell C...	Cetuximab TIP	18 Years -	Centre Leon Berard

Spots Global Cancer Trial Database for squamous cell carcinoma of the penis