Trial Outcomes & Findings for PD-1 Alone or With Dendritic Cell/Renal Cell Carcinoma Fusion Cell Vaccine (NCT NCT01441765)

Last Updated: 2017-02-08

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

11 participants

Primary outcome timeframe

2 years

Results posted on

2017-02-08

Participant Flow

Participant milestones

Participant milestones
Measure	CT-011 CT-011 3 mg/kg for 4 cycles of 6 weeks CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks	CT-011 With DC/RCC Fusion Vaccine CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4
Overall Study STARTED	11	0
Overall Study COMPLETED	10	0
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	CT-011 CT-011 3 mg/kg for 4 cycles of 6 weeks CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks	CT-011 With DC/RCC Fusion Vaccine CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4
Overall Study Death	1	0

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CT-011 n=11 Participants CT-011 3 mg/kg for 4 cycles of 6 weeks CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks	CT-011 With DC/RCC Fusion Vaccine CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4	Total n=11 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	—	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	6 Participants n=5 Participants	—	6 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	—	5 Participants n=5 Participants
Age, Continuous	63 years n=5 Participants	—	63 years n=5 Participants
Gender Female	3 Participants n=5 Participants	—	3 Participants n=5 Participants
Gender Male	8 Participants n=5 Participants	—	8 Participants n=5 Participants
Region of Enrollment United States	11 participants n=5 Participants	—	11 participants n=5 Participants

PRIMARY outcome

Timeframe: 2 years

Outcome measures

Outcome measures
Measure	CT-011 n=10 Participants CT-011 3 mg/kg for 4 cycles of 6 weeks CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks	CT-011 With DC/RCC Fusion Vaccine CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4
Number of Participants With Adverse Events	8 participants	—

PRIMARY outcome

Timeframe: 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."

Outcome measures

Outcome measures
Measure	CT-011 n=10 Participants CT-011 3 mg/kg for 4 cycles of 6 weeks CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks	CT-011 With DC/RCC Fusion Vaccine CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4
Number of Participants With PR or CR at 2 Years	0 participants	—

SECONDARY outcome

Timeframe: 2 years

Population: Data was not analyzed as so few participants were enrolled and none of the participants achieved a PR or CR.

To evaluate immunologic response directed against RCC and tumor specific antigens following therapy with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine. Immunologic response will be characterized as peak response post-therapy and ongoing response at 3 and 6 months following treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

Population: Data was not analyzed as so few participants were enrolled and no participants achieved a PR.

To evaluate the effect of CT-011 alone or in conjunction with DC/RCC fusions on circulating regulatory T cells and PD-1 expression by circulating and bone marrow derived T cells.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 2 years

To evaluate overall survival following treatment with CT-011 alone or CT-011 in conjunction with DC/RCC fusion vaccine.

Outcome measures

Outcome measures
Measure	CT-011 n=10 Participants CT-011 3 mg/kg for 4 cycles of 6 weeks CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks	CT-011 With DC/RCC Fusion Vaccine CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4
Number of Participants Who Survived at 2 Years	4 participants	—

Adverse Events

CT-011

Serious events: 0 serious events

Other events: 8 other events

Deaths: 0 deaths

CT-011 With DC/RCC Fusion Vaccine

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	CT-011 n=10 participants at risk CT-011 3 mg/kg for 4 cycles of 6 weeks CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks	CT-011 With DC/RCC Fusion Vaccine CT-011 with DC/RCC fusion vaccine for subjects undergoing nephrectomy, resection of tumor tissue, or aspiration of malignant effusion CT-011: CT-011 at 3 mg/kg IV for 4 cycles of 6 weeks DC/RCC fusion vaccine: Vaccination once per cycle on Day 8 of treatment cycles 2-4
Gastrointestinal disorders Diarrhea	20.0% 2/10 • Number of events 2	— 0/0
Gastrointestinal disorders Flatulence	10.0% 1/10 • Number of events 1	— 0/0
Investigations Neutropenia	10.0% 1/10 • Number of events 1	— 0/0
Investigations Hyperkalemia	10.0% 1/10 • Number of events 1	— 0/0
Investigations Hypothyroidism	20.0% 2/10 • Number of events 3	— 0/0
Metabolism and nutrition disorders Weight Loss	10.0% 1/10 • Number of events 1	— 0/0
General disorders Pneumonitis	10.0% 1/10 • Number of events 1	— 0/0
Investigations Pruritis	10.0% 1/10 • Number of events 1	— 0/0
General disorders Fever	10.0% 1/10 • Number of events 1	— 0/0
General disorders Rash (back/neck)	10.0% 1/10 • Number of events 1	— 0/0
Investigations Cough	10.0% 1/10 • Number of events 1	— 0/0

Additional Information

Dr. David Avigan, Principal Investigator

Beth Israel Deaconess Medical Center

Phone: 617-667-9920

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place