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NCT02309177
Safety Study of Nivolumab With Nab-Paclitaxel Plus or Minus Gemcitabine in Pancreatic Cancer, Nab-Paclitaxel / Carboplatin in Stage IIIB/IV Non-Small Cell Lung Cancer or Nab-Paclitaxel in Recurrent Metastatic Breast Cancer
Phase 1 trial testing nab-Paclitaxel in Breast Neoplasms in 114 participants. Completed in 12 September 2018.
12 September 2018
Quick facts
| Lead sponsor | Celgene |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 114 |
| Start date | 12 January 2015 |
| Primary completion | 12 September 2018 |
| Estimated completion | 12 September 2018 |
| Sites | 15 locations across United States |
Drugs / interventions tested
- nab-Paclitaxel (nab-paclitaxel) — full drug profile →
- Nivolumab (nivolumab) — full drug profile →
- Gemcitabine (gemcitabine) — full drug profile →
- Carboplatin (Carboplatin) — full drug profile →
Conditions studied
- Breast Neoplasms — all drugs for Breast Neoplasms →
- Pancreatic Neoplasms — all drugs for Pancreatic Neoplasms →
Sponsor
Celgene — full company profile →
Who can join
18 and older, any sex, with Breast Neoplasms or Pancreatic Neoplasms. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this study is to assess safety of nab-paclitaxel based chemotherapy regimens administered prior to and/or in combination with nivolumab in Pancreatic Cancer, Non Small Cell Lung Cancer (NSCLC) and Metastatic Breast Cancer (mBC).
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Mechanisms of immune evasion in breast cancer.
Bates JP, Derakhshandeh R, Jones L, Webb TJ. · · 2018 · cited 206× · PMID 29751789 · DOI 10.1186/s12885-018-4441-3 -
Current and future immunotherapeutic approaches in pancreatic cancer treatment.
Farhangnia P, Khorramdelazad H, Nickho H, Delbandi AA. · · 2024 · cited 153× · PMID 38835055 · DOI 10.1186/s13045-024-01561-6 -
Immune Checkpoint Inhibition for Pancreatic Ductal Adenocarcinoma: Current Limitations and Future Options.
Kabacaoglu D, Ciecielski KJ, Ruess DA, Algül H. · · 2018 · cited 152× · PMID 30158932 · DOI 10.3389/fimmu.2018.01878 -
A Review of Systemic Treatment in Metastatic Triple-Negative Breast Cancer.
Zeichner SB, Terawaki H, Gogineni K. · · 2016 · cited 134× · PMID 27042088 · DOI 10.4137/bcbcr.s32783 -
Pancreatic cancer: optimizing treatment options, new, and emerging targeted therapies.
Chiorean EG, Coveler AL. · · 2015 · cited 133× · PMID 26185420 · DOI 10.2147/dddt.s60328 -
New Strategies in Breast Cancer: Immunotherapy.
Pusztai L, Karn T, Safonov A, Abu-Khalaf MM, et al · · 2016 · cited 108× · PMID 26867935 · DOI 10.1158/1078-0432.ccr-15-1315 -
Combinatorial approach to cancer immunotherapy: strength in numbers.
Vilgelm AE, Johnson DB, Richmond A. · · 2016 · cited 83× · PMID 27256570 · DOI 10.1189/jlb.5ri0116-013rr -
Combinatorial Approach to Improve Cancer Immunotherapy: Rational Drug Design Strategy to Simultaneously Hit Multiple Targets to Kill Tumor Cells and to Activate the Immune System.
Joshi S, Durden DL. · · 2019 · cited 76× · PMID 30853982 · DOI 10.1155/2019/5245034
Verify or expand the search:
- PubMed search for NCT02309177
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT02309177 (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 Celgene
- Last refreshed: 31 May 2019
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/NCT02309177.
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