NCT00064129 is a Phase 1 clinical trial of Ipilimumab in Recurrent Prostate Carcinoma, sponsored by National Cancer Institute (NCI).

Who is sponsoring NCT00064129?

NCT00064129 is sponsored by National Cancer Institute (NCI).

What drugs are being tested in NCT00064129?

Interventions in NCT00064129: Ipilimumab, Laboratory Biomarker Analysis, Pharmacological Study, Sargramostim.

What condition does NCT00064129 study?

NCT00064129 studies Recurrent Prostate Carcinoma, Stage IV Prostate Cancer AJCC v7.

Is NCT00064129 still recruiting?

NCT00064129 is currently completed. Last updated 30 July 2020.

Last reviewed 2020-07-30 · How we verify

NCT00064129

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Ipilimumab and Sargramostim in Treating Patients With Metastatic Prostate Cancer

Completed Phase 1 Last updated 30 July 2020

What this trial tests

Phase 1 trial testing Ipilimumab in Recurrent Prostate Carcinoma in 42 participants. Completed in 1 October 2012.

Timeline

13 May 2003

Primary endpoint
10 January 2011

1 October 2012

Quick facts

Lead sponsor	National Cancer Institute (NCI)
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	42
Start date	13 May 2003
Primary completion	10 January 2011
Estimated completion	1 October 2012
Sites	1 location across United States

Drugs / interventions tested

Ipilimumab — full drug profile →
Laboratory Biomarker Analysis — full drug profile →
Pharmacological Study — full drug profile →
Sargramostim (SARGRAMOSTIM) — full drug profile →

Conditions studied

Recurrent Prostate Carcinoma — all drugs for Recurrent Prostate Carcinoma →
Stage IV Prostate Cancer AJCC v7 — all drugs for Stage IV Prostate Cancer AJCC v7 →

Sponsor

National Cancer Institute (NCI)

Who can join

18 and older, male only, with Recurrent Prostate Carcinoma or Stage IV Prostate Cancer AJCC v7. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This phase I trial is studying the side effects and best dose of ipilimumab when given with sargramostim in treating patients with metastatic prostate cancer. Monoclonal antibodies can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Colony-stimulating factors, such as sargramostim, may increase the number of immune cells found in bone marrow or peripheral blood and may help a person's immune system kill more tumor cells.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

Regulatory T Cells in the Tumor Microenvironment and Cancer Progression: Role and Therapeutic Targeting.
Chaudhary B, Elkord E. · · 2016 · cited 359× · PMID 27509527 · DOI 10.3390/vaccines4030028
Improved survival with T cell clonotype stability after anti-CTLA-4 treatment in cancer patients.
Cha E, Klinger M, Hou Y, Cummings C, et al · · 2014 · cited 328× · PMID 24871131 · DOI 10.1126/scitranslmed.3008211
At the bedside: CTLA-4- and PD-1-blocking antibodies in cancer immunotherapy.
Callahan MK, Wolchok JD. · · 2013 · cited 246× · PMID 23667165 · DOI 10.1189/jlb.1212631
CTLA4 blockade expands FoxP3+ regulatory and activated effector CD4+ T cells in a dose-dependent fashion.
Kavanagh B, O'Brien S, Lee D, Hou Y, et al · · 2008 · cited 200× · PMID 18523152 · DOI 10.1182/blood-2007-11-125435
Immune Toxicities Elicted by CTLA-4 Blockade in Cancer Patients Are Associated with Early Diversification of the T-cell Repertoire.
Oh DY, Cham J, Zhang L, Fong G, et al · · 2017 · cited 194× · PMID 28031229 · DOI 10.1158/0008-5472.can-16-2324
CD8<sup>+</sup> T cell-based cancer immunotherapy.
Chen Y, Yu D, Qian H, Shi Y, et al · · 2024 · cited 63× · PMID 38685033 · DOI 10.1186/s12967-024-05134-6
Diversity of antigen-specific responses induced in vivo with CTLA-4 blockade in prostate cancer patients.
Kwek SS, Dao V, Roy R, Hou Y, et al · · 2012 · cited 61× · PMID 22956585 · DOI 10.4049/jimmunol.1201529
Unmasking the immune recognition of prostate cancer with CTLA4 blockade.
Kwek SS, Cha E, Fong L. · · 2012 · cited 42× · PMID 22378189 · DOI 10.1038/nrc3223

Verify or expand the search:

Other trials of Ipilimumab

Trials testing the same drug.

NCT07444619 — A Phase I Study of Pazopanib in Combination With Trabectedin, Ipilimumab and Nivolumab (TraPIN) in Pediatric and Young A · Phase 1 · not yet recruiting
NCT07383441 — Adding Biotherapy or Placebo to Standard Treatment for Advanced Kidney Cancer · Phase 3 · not yet recruiting
NCT07510334 — VSV-IFNβ-NIS With Ipilimumab and Nivolumab for the Treatment of Advanced or Metastatic Clear Cell Renal Cell Carcinoma · Phase 2 · not yet recruiting
NCT07293351 — A Study to Evaluate the Safety, Tolerability, and Efficacy of Pumitamig Alone or in Combination With Ipilimumab or Caboz · Phase 1, PHASE2 · recruiting
NCT07128680 — Immunotherapy (Nivolumab and Ipilimumab) With and Without a Live Biotherapeutic Product (EXL01) for the Treatment of Met · Phase 1 · recruiting

Other recruiting trials for Recurrent Prostate Carcinoma

Currently open trials in the same condition.

NCT07202247 — Metabolic Interventions (Time-Restricted Eating, GLP1 Receptor Agonist, and Heart Healthy Diet) to Improve Cardiometabol · Phase 2 · recruiting
NCT06650579 — REVELUTION-2: Relugolix+Abiraterone Acetate (AA) Versus Leuprolide+AA Cardiac Trial · Phase 3 · recruiting
NCT05779943 — Comparison of 18F-rhPSMA-7.3 PET/CT With and Without Furosemide in Biochemical Recurrence of Prostate Cancer · Phase 2 · active not recruiting
NCT05722288 — Time-Restricted Eating Versus Nutritional Counseling for the Reduction of Radiation or Chemoradiation Tx Side Effects in · Phase 2 · recruiting
NCT04514484 — Testing the Combination of the Anti-cancer Drugs XL184 (Cabozantinib) and Nivolumab in Patients With Advanced Cancer and · Phase 1 · active not recruiting

Other National Cancer Institute (NCI) trials

Trials by the same sponsor.

NCT07147231 — Testing the Effectiveness of the Anti-cancer Drug Pidnarulex (CX-5461), in Combination With Another Anti-cancer Drug Cem · Phase 1, PHASE2 · recruiting
NCT07572123 — Evaluating the Addition of Maintenance Immunotherapy Compared to the Usual Treatment of Chemotherapy and Autologous Stem · Phase 2, PHASE3 · not yet recruiting
NCT07281417 — Testing the Addition of Cemiplimab (REGN2810) to Chemotherapy Treatment Given Prior to Surgery in Patients With Sinonasa · Phase 2 · recruiting
NCT07012044 — A Study to Find the Highest Dose of Cedazuridine and Decitabine Combination With Filgrastim as a Treatment Option After · Phase 1 · not yet recruiting
NCT07437950 — Comparing Different Treatment Lengths for Venetoclax in Older People With Newly Diagnosed Acute Myeloid Leukemia (A Myel · Phase 2 · not yet recruiting

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT00064129 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by National Cancer Institute (NCI)
Last refreshed: 30 July 2020

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00064129.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing