PD-1 Alone or With Dendritic Cell/Renal Cell Carcinoma Fusion Cell Vaccine

NCT01441765 | Terminated Phase 2 Results DMC

• 2 other identifiers: 11-178P50CA101942-06A1
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief Summary

CT-011 is an investigational monoclonal antibody. Monoclonal antibodies are a type of drug that are known to target specific cells (in this case, cells in the immune system) The DC RCC Vaccine is agent that tries to help the immune system to recognize and fight against cancer cells. The purpose of this research study is to determine the safety of CT-011 alone, and in combination with the Dendritic Cell Renal Cell Carcinoma (DC RCC) vaccine. The investigators are also trying to find out what effect the combination has on the disease, and on your immune system.

Conditions

Renal Cell Carcinoma

Keywords

Kidney; Metastatic; Stage IV

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Adverse Events

  Assessment of toxicity associated with treating patients with metastatic RCC with CT-011 alone or CT-011 in conjunction with DC/RCC. Toxicity was assessed and classified according to CTCAE Version 4.0.

  2 years

• Number of Participants With PR or CR at 2 Years

  To evaluate the complete and partial response rate following completing 4 cycles of CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR. Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, (with an absolute increase of at least 5 mm), or the appearance of new lesions. Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study."

  2 years

Secondary Outcomes (3)

• Immunologic Response

  2 years

• Effect on Circulating Regulatory T Cells

  2 years

• Number of Participants Who Survived at 2 Years

  2 years

Study Arms (2)

CT-011

ACTIVE COMPARATOR

CT-011 3 mg/kg for 4 cycles of 6 weeks

Drug: CT-011

CT-011 with DC/RCC fusion vaccine

ACTIVE COMPARATOR

CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion

Drug: CT-011; Biological: DC/RCC fusion vaccine

Interventions

CT-011 DRUG

CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks

CT-011; CT-011 with DC/RCC fusion vaccine

DC/RCC fusion vaccine BIOLOGICAL

Vaccination once per cycle on Day 8 of treatment cycles 2-4

CT-011 with DC/RCC fusion vaccine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Stage IV renal cancer
• Measurable disease
• Life expectancy \> 3 months
• Adequate organ and marrow function

You may not qualify if:

• Clinical evidence of central nervous system (CNS) disease. Subjects with a history of treated brain metastasis must be stable with no evidence of disease for 3 months
• Clinically significant autoimmune disease
• HIV+
• Serious intercurrent illness such as infection requiring intravenous (IV) antibiotics, or significant cardiac disease characterized by significant arrhythmia, uncontrolled hypertension, unstable ischemic coronary disease or congestive heart failure
• Pregnant or lactating
• History of clinically significant venous thromboembolism (For Cohort 2)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead
• National Institutes of Health (NIH): collaborator
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

MeSH Terms

Conditions

Carcinoma, Renal Cell; Neoplasm Metastasis

Interventions

pidilizumab

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Kidney Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Kidney Diseases; Urologic Diseases; Male Urogenital Diseases; Neoplastic Processes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Due to lack of funding, the study was terminated early without completing enrollment.

Results Point of Contact

• Title: Dr. David Avigan, Principal Investigator
• Organization: Beth Israel Deaconess Medical Center

davigan@bidmc.harvard.edu

617-667-9920

Study Officials

• David Avigan, MD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: September 22, 2011
• First Posted: September 28, 2011
• Study Start: November 1, 2011
• Primary Completion: July 1, 2016
• Study Completion: July 1, 2016
• Last Updated: February 8, 2017
• Results First Posted: November 9, 2016

Record last verified: 2016-12

Locations

US (1)