Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Rare Diseases

Carcinoma, Renal Cell

Kidney Neoplasms

Carcinoma

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Kidney Diseases

Urologic Diseases

Male Urogenital Diseases

Adenocarcinoma

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Renal Cell Carcinoma

All Drugs and Chemicals

Antineoplastic Agents

Amino Acids

Antibodies

Antibodies, Monoclonal

Immunoglobulins

Sunitinib

Tyrosine Kinase Inhibitors

Angiogenesis Inhibitors

Growth Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tyrosine

TQB2450 1200 mg administered intravenously (IV) on Day 1 of each 21-day cycle ,Anlotinib capsules 12 mg given orally, once daily in 21-day cycle (14 days on treatment from Day 1-14, 7 days off treatment from Day 15-21).

Sunitinib malate capsule 50mg administered orally, once daily in 28-day cycle(14 days on treatment from Day 1-14, 14 days off treatment from day 15-28).

TQB2450 is a humanized monoclonal antibody targeting programmed death ligand-1 (PD-L1), which prevents PD-L1 from binding to PD-1 and B7.1 receptors on T cell surface, restores T cell activity, thus enhancing immune response and has potential to treat various types of tumors.

TQB2450

A multi-target receptor tyrosine kinase inhibitor.

Anlotinib

Jun Guo, Doctor

Dexin Yu, Master

Aiping Zhou, Doctor

Xiaofeng Zhou, Doctor

Zhigang Ji

Zhisong He

Lulin Ma

Shunchang Jiao, Doctor

Yuan Li

Tongjian Cui, Master

Fangjian Zhou, Doctor

Jin Wu, Doctor

Weiqing Han

Hongqian Guo, Doctor

Xinhua Tu

Ziling Liu, Doctor

Man Li, Doctor

Cheng Fu

Benkang Shi, Doctor

Xudong Yao, Doctor

Weijun Qin, Doctor

Pengfei Shen, Doctor

Xiubao Ren, Doctor

Ping Gong, Doctor

Peng Chen, Master

Shaoxing Zhu, Doctor

This study is a randomized, positive parallel controlled, multicentre phase III clinical trial to evaluate the efficacy and safety of TQB2450 combined with anlotinib versus sunitinib in subjects with advanced renal cancer.

A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

A Randomized, Positive Parallel Controlled, Multicenter Phase III Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on IRC.

PFS defined as the time from randomization until the first documented progressive disease (PD) or death from any cause, based on investigator.

OS defined as the time from randomization to death from any cause. Participants who do not die at the end of the extended follow-up period, or were lost to follow-up during the study, were censored at the last date they were known to be alive.

Percentage of participants achieving complete response (CR) and partial response (PR) and stable disease (SD).

The time when the participants first achieved complete or partial remission to disease progression.

Percentage of participants whose PFS has achieved at least 12 months.

Percentage of participants whose OS has achieved at least 12 months.

Percentage of participants whose OS has achieved at least 24 months.

Chia Tai Tianqing Pharmaceutical Group Co., Ltd.

Clear Cell Renal Cell Carcinoma

Immunoconjugates

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.2 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.3 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.4 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.45 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients initially received a nontherapeutic injection of \^111In-DOTA-cG250 (5 mCi \^111In + 10 mg cG250) on Day 1. Pending satisfaction of protocol-specified lesion targeting criteria, a single dose of therapeutic \^90Y-DOTA-cG250 (0.55 mCi/kg \^90Y + 10 mg cG250) was administered on Day 8, 9, or 10 as a continuous IV infusion over approximately 5 to 15 minutes.

Patients received a single infusion of \^90Y-DOTA-cG250, with escalating doses administered to sequentially enrolled cohorts until MTD determination.

Yttrium-90 conjugated chimeric G250 (^90Y-DOTA-cG250)

Steven Larson, MD

Neeta Pandit-Taskar, MD

Joseph O'Donoghue, PhD

Robert Motzer, MD

This was a Phase 1, open-label, dose-escalation study of yttrium-90 conjugated chimeric G250 (\^90Y-DOTA-cG250) in patients with advanced, measurable clear cell renal cell carcinoma (RCC). Study objectives were to determine the safety, targeting, and dosimetry of \^90Y-DOTA-cG250, using indium-111 conjugated chimeric G250 (\^111In-DOTA-cG250) as a surrogate, as well as to evaluate the immunogenicity of cG250.

Patients were enrolled sequentially into cohorts of 3 to 6 patients until determination of the maximum tolerated dose (MTD) of \^90Y-DOTA-cG250, defined as the dose level below the dose at which ≥ 2 patients experienced dose-limiting toxicity (DLT). In an attempt to mitigate liver uptake and toxicity, patients initially received a nontherapeutic injection with \^111In-DOTA-cG250 at an imaging dose of 5 mCi of \^111In + 10 mg of cG250 on Day 1. Whole body and blood measurements of radioactivity were obtained on at least 3 occasions for 1 week to determine targeting and dosimetry. Provided that protocol-specified criteria were met, including targeting to lesions \> 2 cm detected on computed tomography (CT) scan, a single dose of therapeutic \^90Y-DOTA-cG250 was administered on Day 8, 9, or 10. The starting dose of \^90Y-DOTA-cG250 was 0.2 mCi/kg of \^90Y + 10 mg of cG250 administered as an intravenous (IV) infusion, with escalation of the \^90Y dose in subsequent cohorts in 0.05 to 0.1 mCi/kg increments.

Patients were treated in an outpatient setting and were observed for at least 2 hours following each infusion, at which point vital signs and blood samples were obtained. Patients were followed for 6 to 8 weeks post-treatment (or after recovery from toxicity) with imaging, biochemical, serological, and hematologic tests to determine the safety of \^90Y-DOTA-cG250 and to inform dose-escalation decisions. Extent of disease evaluations, preferably by positron emission tomography (PET)/CT or standard CT, were performed at baseline and 6 to 8 weeks post-treatment (or after recovery from toxicity). Long-term follow-up was performed, when possible, every 12 weeks thereafter for up to 2 years.

Patients were enrolled sequentially in cohorts of 3 to 6 patients to receive escalating doses of study treatment until determination of the MTD.

Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250

Cohort Study of Increasing Doses of Yttrium-90 Conjugated to Chimeric Monoclonal Antibody cG250 (^90Y-DOTA-cG250) in Patients With Advanced Renal Cancer

Toxicity was graded in accordance with the National Cancer Institute (NCI) Common Toxicity Criteria (CTC), version 3.0. Treatment-emergent adverse events (TEAEs) were reported based on clinical laboratory tests, physical examinations, and vital signs from pre-treatment through the study period. Dose-limiting toxicity (DLT) was defined as follows for the purposes of dose escalation: Grade 4 hematopoietic toxicity in excess of 5 days or Grade 3 or greater nonhematopoietic toxicity.

In order to receive the therapeutic \^90Y-DOTA-cG250 injection on Day 8, 9, or 10, patients must have demonstrated tumor targeting to lesions \> 2 cm detected by CT scan and must not have exhibited the following characteristics following the nontherapeutic injection of \^111In-DOTA-cG250: excessive liver and/or spleen uptake; excessive uptake in the normal kidney; non-visualization of the cardiac blood pool in the first imaging set; whole body clearance half-life (t1/2) \< 1.5 days; serum t1/2 \< 2 days; rapid clearance of the radiopharmaceutical from the blood pool with prominent marrow uptake on the first image.

Blood samples were drawn for evaluation of the human antichimeric antibody (HACA) at screening, between Days 22 and 28, between Days 36 and 42, between Days 43 and 57 or at the end of study, and during long-term follow-up (approximately 12 weeks later). Serial dilutions were tested by the enzyme-linked immunosorbent assay (ELISA) using the "double antibody sandwich" technique and pretreatment serum as negative control.

Memorial Sloan Kettering Cancer Center

Ludwig Institute for Cancer Research

AE documentation included onset/resolution dates, severity using the NCI CTC (version 3.0), seriousness, study drug action taken, treatment, and outcome. In summaries, treatment-related AEs included those with a "possible", "probable", or "definite" relationship to study drug; preferred terms were counted only once per patient at the maximum reported grade.

Cohort 1 (0.2 mCi/kg)

Cohort 2 (0.3 mCi/kg)

Cohort 3 (0.4 mCi/kg)

Cohort 4 (0.45 mCi/kg)

Cohort 5 (0.55 mCi/kg)

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Missing

Higher performance status indicates higher functional abilities, as follows:

100=Normal, no complaints/evidence of disease. 90=Able to carry on normal activity; minor signs/symptoms of disease. 80=Normal activity with effort; some signs/symptoms of disease. 70=Cares for self; unable to carry on normal activity or do active work. 60=Requires occasional assistance but is able to care for most personal needs. 50=Requires considerable assistance \& frequent medical care. 0-40=Unable to care for self; requires equivalent of institutional or hospital care; disease may be progressing rapidly.

Karnofsky Performance Status

The Safety Analysis Set includes all patients who received at least 1 dose of study treatment.

Jonathan Skipper PhD

Any TEAE

Maximum grade 1 TEAE

Maximum grade 2 TEAE

Maximum grade 3 TEAE

Maximum grade 4 TEAE

Treatment-related TEAE

Serious TEAE

TEAE Leading to Treatment Discontinuation

TEAE Meeting DLT Criteria

Number of Patients With Treatment-emergent Adverse Events

Number of Patients Who Met Protocol-Specified Criteria to Receive ^90-Y-DOTA-cG250 Following ^111In-DOTA-cG250 Administration

Baseline

Day 28

Day 42

Day 63

Long-term Follow-up

Number of Patients With Samples Collected for Evaluation of Human Antichimeric Antibody

Overall Study

Anti-Infective Agents

Vaccines

Interferons

Interferon-alpha

Antiviral Agents

Immunologic Factors

16 Intramuscular injections of TroVax® over 47 weeks

TroVax® (Immunological Vaccine Therapy)

36 subcutaneous IFN-α injections for 12 weeks. sc injection three times per week (5MU each)

Robert J Amato, DO

Patients with metastatic renal cell cancer will be enrolled to receive either Trovax® alone or Trovax® plus Interferon Alfa. The study will try to determine whether the use of Trovax® will delay tumor progression.

Patients with metastatic renal cell cancer will be enrolled in the study if all inclusion/exclusion criteria are met. Once the patient is enrolled, and baseline tests have been completed, the patient will start treatment.

Trovax® alone arm:

Trovax will be given as an intramuscular injection every two weeks for the first two months, then once a month for the next 2 months, and then once every 2 months for up to a year.

Trovax® plus IFN-α:

Trovax® schedule will be the same as the Trovax® alone arm. IFN will be given on the first, third and fifth day of the week for a total of twelve weeks.

At every office visit vital signs will be taken. Every eight weeks a medical history, physical exam, performance status evaluation, chest x-ray or CT scan, abdomen/pelvis CT scan or MRI will be done. A blood sample (about 8-10 tablespoons) will be taken to test the immunological response to TroVax® on the same days that the patient receives TroVax® injections.

Safety Study of TroVax Alone vs. TroVax Plus Interferon Alpha in Patients With Renal Cancer

A Phase II Trial to Assess the Activity of TroVax® Alone vs. TroVax® Plus Interferon Alfa (IFN-α) on Patients With Advanced or Metastatic Renal Cell Cancer

Oxford BioMedica

The Methodist Hospital Research Institute

Skin and Connective Tissue Diseases

Gland and Hormone Related Diseases

Digestive System Diseases

Prostatic Neoplasms

Breast Neoplasms

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Colonic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

Endocrine Gland Neoplasms

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Neoplasms, Female

Endocrine System Diseases

Gonadal Disorders

Colorectal Neoplasms

Intestinal Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Colonic Diseases

Intestinal Diseases

Ovarian Cancer

Ovarian Epithelial Cancer

Antirheumatic Agents

Herbal and Botanical

Cyclophosphamide

Hormones

Immunosuppressive Agents

Antineoplastic Agents, Alkylating

Alkylating Agents

Cola

Patients who meet all entry criteria will be administered 600 mg/m\^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

Cyclophosphamide & ZYC300 (ZYC300 with cyclophosphamide pre-dosing)

Michael Silverman, MD

The purpose of this study is to evaluate the feasibility, safety, and tolerability of administering ZYC300 with Cyclophosphamide (Cytoxan).

This is an open-label study of ZYC300 in the treatment of advanced stage malignancy of the kidney in patients who have not had previous immune-based therapies or treatment of advanced stage malignancies (cancerous growths) of the ovary, breast, colon, or hormone-refractory prostate in patients who have failed at least one but no more than two prior regimens of chemotherapy. Patients who meet all entry criteria will be administered 600 mg/m\^2 cyclophosphamide intravenously 3 days before each dose of ZYC300. ZYC300 will be administered at 400 micrograms DNA/total dose every two weeks for a maximum of six doses (6 cycles).

ZYC300 is a plasmid DNA formulated within biodegradable microencapsulated particles. This is the first time that ZYC300 and Cyclophosphamide will be given together. Cyclophosphamide is a chemotherapy drug approved by the FDA that has been used for many years in many different kinds of cancer. In this trial the study drug will be used to boost the immune system. Sometimes the immune system cannot fight infected or abnormal cells because of other cells called T reg cells. The T reg cells limit the immune systems attack on infected or abnormal cells. In this study, the hope is that Cyclophosphamide will inhibit the T regs cells so that the ZYC300 can work better to attack the cancer cells.

A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing

A Phase 1 Open-Label Study of the Safety and Feasibility of ZYC300 Administration With Cyclophosphamide Pre-Dosing

Eisai Inc.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer	NCT04523272	Advanced Renal ...	TQB2450 Anlotinib Sunitinib	18 Years - 80 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250	NCT00199875	Renal Cell Carc... Kidney Neoplasm Renal Cancer Kidney Cancer	Yttrium-90 conj...	18 Years -	Ludwig Institute for Cancer Research
Safety Study of TroVax Alone vs. TroVax Plus Interferon Alpha in Patients With Renal Cancer	NCT00445523	Carcinoma, Rena...	TroVax® (Immuno... Interferon-alph...	18 Years -	The Methodist Hospital Research Institute
A Study of TQB2450 Injection Combined With Anlotinib Hydrochloride Capsule Versus Sunitinib in Subjects With Advanced Renal Cancer	NCT04523272	Advanced Renal ...	TQB2450 Anlotinib Sunitinib	18 Years - 80 Years	Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
A Study of ZYC300 Administered With Cyclophosphamide Pre-Dosing	NCT00381173	Breast Cancer Ovarian Cancer Prostate Cancer Colon Cancer Renal Cancer	Cyclophosphamid...	18 Years -	Eisai Inc.
Treatment of Patients With Advanced Renal Cancer With a Radiolabeled Antibody, Yttrium-90 Conjugated Chimeric G250	NCT00199875	Renal Cell Carc... Kidney Neoplasm Renal Cancer Kidney Cancer	Yttrium-90 conj...	18 Years -	Ludwig Institute for Cancer Research

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