Trial · NCT02159950

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

NCT02159950, Phase 2, Completed, Roswell Park Cancer Institute; results first posted 2016-05-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer. Trials, record NCT02159950. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02159950

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Sipuleucel-T With or Without Tasquinimod in Treating Patients With Metastatic Hormone-Resistant Prostate Cancer
NCT number: NCT02159950
Status: Completed
Phases: Phase 2
Enrollment: 2 participants, actual
Lead sponsor: Roswell Park Cancer Institute
Conditions: Hormone-Resistant Prostate Cancer, Metastatic Prostate Carcinoma, Recurrent Prostate Carcinoma, Stage IV Prostate Cancer
Interventions: Laboratory Biomarker Analysis, Sipuleucel-T, Tasquinimod
First posted: 2014-06-10
Last updated: 2023-04-27
Results first posted: 2016-05-20
Limitations and caveats: Due to the study's early closure, as a result of lack of funding, target accrual was not reached and no statistical inference of the primary and secondary aims were carried forth.

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024	Baseline up to 50 weeks
Secondary	Change in PSA Response	Baseline to up to 3 years	PSA doubling time, PSA slope
Secondary	Duration of PSA Response	Up to 3 years
Secondary	Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4	Up to 3 years	The frequency of participants with toxicities will be tabulated by grade across all dose levels and courses.
Secondary	Immune Response	Week 6
Secondary	Immune Response	Week 10
Secondary	Immune Response	Week 26
Secondary	Immune Response	Week 50
Secondary	Immune Response (Arm 2 Only)	Week 0
Secondary	Objective Response Rates (Partial or Complete)	Up to 3 years

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change in Immune Response Assessed by IFN-g ELISPOT Specific for PA2024	Baseline up to 50 weeks	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Change in PSA Response	Baseline to up to 3 years	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Duration of PSA Response	Up to 3 years	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4	Up to 3 years	All treated and eligible patients.	participants	NUMBER
SECONDARY	Immune Response	Week 6	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Immune Response	Week 10	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Immune Response	Week 26	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Immune Response	Week 50	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Immune Response (Arm 2 Only)	Week 0	Due a Lack of funding data was not collected and no patients were analyzed.
SECONDARY	Objective Response Rates (Partial or Complete)	Up to 3 years	Due a Lack of funding data was not collected and no patients were analyzed.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group2

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4	Arm II (Tasquinimod, Sipuleucel-T)	Grade 1	1		participants
Frequency of Toxicities Assessed by the National Cancer Institute Common Terminology Criteria for Adverse Events Version 4	Arm II (Tasquinimod, Sipuleucel-T)	Grade 4	1		participants

Source ClinicalTrials.gov

Participant flow6

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Arm I (Sipuleucel-T)	0
Overall Study	STARTED	Arm II (Tasquinimod, Sipuleucel-T)	2
Overall Study	COMPLETED	Arm I (Sipuleucel-T)	0
Overall Study	COMPLETED	Arm II (Tasquinimod, Sipuleucel-T)	0
Overall Study	NOT COMPLETED	Arm I (Sipuleucel-T)	0
Overall Study	NOT COMPLETED	Arm II (Tasquinimod, Sipuleucel-T)	2

Source ClinicalTrials.gov

Adverse events22

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	Anaemia	Blood and lymphatic system disorders	Arm I (Sipuleucel-T)	0	0	0
other	Anaemia	Blood and lymphatic system disorders	Arm II (Tasquinimod, Sipuleucel-T)	1	2	23
other	Abdominal discomfort	Gastrointestinal disorders	Arm I (Sipuleucel-T)	0	0	0
other	Abdominal discomfort	Gastrointestinal disorders	Arm II (Tasquinimod, Sipuleucel-T)	1	2	30
other	Constipation	Gastrointestinal disorders	Arm I (Sipuleucel-T)	0	0	0
other	Constipation	Gastrointestinal disorders	Arm II (Tasquinimod, Sipuleucel-T)	2	2	10
other	Diarrhoea	Gastrointestinal disorders	Arm I (Sipuleucel-T)	0	0	0
other	Diarrhoea	Gastrointestinal disorders	Arm II (Tasquinimod, Sipuleucel-T)	2	2	57
other	Fatigue	General disorders	Arm I (Sipuleucel-T)	0	0	0
other	Fatigue	General disorders	Arm II (Tasquinimod, Sipuleucel-T)	2	2	27

1 to 10 of 22Source ClinicalTrials.gov

See all 22 adverse events

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Arm I (Sipuleucel-T)
Total, all-cause mortality	Arm II (Tasquinimod, Sipuleucel-T)
Total, other adverse events	Arm I (Sipuleucel-T)	0	0
Total, other adverse events	Arm II (Tasquinimod, Sipuleucel-T)	2	2
Total, serious adverse events	Arm I (Sipuleucel-T)	0	0
Total, serious adverse events	Arm II (Tasquinimod, Sipuleucel-T)	1	2

Source ClinicalTrials.gov

Papers0

The papers the trial lists on ClinicalTrials.gov.

None in this release.

Grants1

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

Project	Title	Principal investigators	Organization	Funder	Fiscal years
P30CA016056	Roswell Park Cancer Center Support Grant	JOHNSON, CANDACE S	ROSWELL PARK CANCER INSTITUTE CORP	NATIONAL CANCER INSTITUTE	1985 to 2025

Source NIH RePORTER

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT02159950

GET https://conductscience.org/api/trials/v1/NCT02159950/events?page=2

API reference For AI assistants