Trial Outcomes & Findings for Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer (NCT NCT02159950)

NCT ID: NCT02159950

Last Updated: 2023-04-27

Results Overview

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 2 participants
• Primary outcome timeframe: Baseline up to 50 weeks
• Results posted on: 2023-04-27

Participant Flow

Participant milestones

Measure	Arm I (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV	Arm II (Tasquinimod, Sipuleucel-T) Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO
Overall Study STARTED	0	2
Overall Study COMPLETED	0	0
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Arm I (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV	Arm II (Tasquinimod, Sipuleucel-T) Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO
Overall Study Adverse Event	0	1
Overall Study Progression	0	1

Baseline Characteristics

Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer

Baseline characteristics by cohort

Measure	Arm I (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV	Arm II (Tasquinimod, Sipuleucel-T) n=2 Participants Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO	Total n=2 Participants Total of all reporting groups
Age, Categorical <=18 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical >=65 years	—	2 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	—	75.4 years STANDARD_DEVIATION .70 • n=7 Participants	75.4 years STANDARD_DEVIATION .70 • n=5 Participants
Sex: Female, Male Female	—	0 Participants n=7 Participants	0 Participants n=5 Participants
Sex: Female, Male Male	—	2 Participants n=7 Participants	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline up to 50 weeks

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Baseline to up to 3 years

Population: Due a Lack of funding data was not collected and no patients were analyzed.

PSA doubling time, PSA slope

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: All treated and eligible patients.

The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.

Outcome measures

Measure	Arm I (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV	Arm II (Tasquinimod, Sipuleucel-T) n=2 Participants Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO
Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 Grade 1	—	1 participants
Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4 Grade 4	—	1 participants

SECONDARY outcome

Timeframe: Week 6

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 10

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 26

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 50

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Week 0

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 3 years

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to week 50

Population: Due a Lack of funding data was not collected and no patients were analyzed.

Outcome measures

Outcome data not reported

Adverse Events

Arm I (Sipuleucel-T)

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Arm II (Tasquinimod, Sipuleucel-T)

Serious events: 1 serious events

Other events: 2 other events

Deaths: 0 deaths

Serious adverse events

Measure	Arm I (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV	Arm II (Tasquinimod, Sipuleucel-T) n=2 participants at risk Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO
Gastrointestinal disorders Pancreatitis	— 0/0	50.0% 1/2 • Number of events 8

Other adverse events

Measure	Arm I (Sipuleucel-T) Patients receive sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV	Arm II (Tasquinimod, Sipuleucel-T) n=2 participants at risk Patients receive tasquinimod PO QD beginning on day -14 and sipuleucel-T IV over 60 minutes on day 4. Treatment repeats every 2 weeks for 3 courses in the absence of disease progression or unacceptable toxicity. Patients continue on tasquinimod treatment after day 42 until disease progression. Laboratory Biomarker Analysis: Correlative studies Sipuleucel-T: Given IV Tasquinimod: Given PO
Blood and lymphatic system disorders Anaemia	— 0/0	50.0% 1/2 • Number of events 23
Gastrointestinal disorders Abdominal discomfort	— 0/0	50.0% 1/2 • Number of events 30
Gastrointestinal disorders Constipation	— 0/0	100.0% 2/2 • Number of events 10
Gastrointestinal disorders Diarrhoea	— 0/0	100.0% 2/2 • Number of events 57
General disorders Fatigue	— 0/0	100.0% 2/2 • Number of events 27
General disorders Malaise	— 0/0	50.0% 1/2 • Number of events 18
Investigations Weight decreased	— 0/0	50.0% 1/2 • Number of events 8
Metabolism and nutrition disorders Decreased appetite	— 0/0	50.0% 1/2 • Number of events 13
Renal and urinary disorders Hydronephrosis	— 0/0	50.0% 1/2 • Number of events 3
Vascular disorders Hypotension	— 0/0	50.0% 1/2 • Number of events 24

Additional Information

Senior Administrator, Compliance - Clinical Research Services

Roswell Park Cancer Institute

Phone: 716-845-2300

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place