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NCT03081494
Phase Ib Study of PDR001 in Combination With Regorafenib in Adult Patients With Previously Treated Metastatic Colorectal Cancer
Phase 1 trial testing spartalizumab (PDR001) in Metastatic Colorectal Cancer in 10 participants. Completed in 7 May 2019.
7 May 2019
Quick facts
| Lead sponsor | Novartis Pharmaceuticals |
|---|---|
| Phase | Phase 1 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 10 |
| Start date | 9 June 2017 |
| Primary completion | 7 May 2019 |
| Estimated completion | 7 May 2019 |
| Sites | 11 locations across Italy, Netherlands, Israel, South Korea, Canada, Australia, Singapore, Spain |
Drugs / interventions tested
- spartalizumab (PDR001) — full drug profile →
- regorafenib — full drug profile →
Conditions studied
- Metastatic Colorectal Cancer — all drugs for Metastatic Colorectal Cancer →
Sponsor
Novartis Pharmaceuticals — full company profile →
Who can join
18 and older, any sex, with Metastatic Colorectal Cancer. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
This was a phase Ib study of PDR001 in combination with regorafenib in adult patients with previously treated metastatic microsatellite stable (MSS) colorectal cancer. The study assessed primarily the safety and tolerability of PDR001 in combination with regorafenib.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
-
Enhancing cancer immunotherapy using antiangiogenics: opportunities and challenges.
Fukumura D, Kloepper J, Amoozgar Z, Duda DG, et al · · 2018 · cited 1560× · PMID 29508855 · DOI 10.1038/nrclinonc.2018.29 -
Immunotherapy in colorectal cancer: rationale, challenges and potential.
Ganesh K, Stadler ZK, Cercek A, Mendelsohn RB, et al · · 2019 · cited 1407× · PMID 30886395 · DOI 10.1038/s41575-019-0126-x -
Comprehensive review of targeted therapy for colorectal cancer.
Xie YH, Chen YX, Fang JY. · · 2020 · cited 1162× · PMID 32296018 · DOI 10.1038/s41392-020-0116-z -
Immunotherapy with immune checkpoint inhibitors in colorectal cancer: what is the future beyond deficient mismatch-repair tumours?
Huyghe N, Baldin P, Van den Eynde M. · · 2020 · cited 79× · PMID 32104582 · DOI 10.1093/gastro/goz061 -
Molecular mechanisms targeting drug-resistance and metastasis in colorectal cancer: Updates and beyond.
Al Bitar S, El-Sabban M, Doughan S, Abou-Kheir W. · · 2023 · cited 53× · PMID 36998426 · DOI 10.3748/wjg.v29.i9.1395 -
Expanding the Scope of Immunotherapy in Colorectal Cancer: Current Clinical Approaches and Future Directions.
Kreidieh M, Mukherji D, Temraz S, Shamseddine A. · · 2020 · cited 38× · PMID 32090113 · DOI 10.1155/2020/9037217 -
Photodynamic Therapy and Hyperthermia in Combination Treatment-Neglected Forces in the Fight against Cancer.
Bienia A, Wiecheć-Cudak O, Murzyn AA, Krzykawska-Serda M. · · 2021 · cited 36× · PMID 34452108 · DOI 10.3390/pharmaceutics13081147 -
The Emerging Role of Checkpoint Inhibition in Microsatellite Stable Colorectal Cancer.
Hermel DJ, Sigal D. · · 2019 · cited 26× · PMID 30654522 · DOI 10.3390/jpm9010005
Verify or expand the search:
- PubMed search for NCT03081494
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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Other Novartis Pharmaceuticals trials
Trials by the same sponsor.
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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 NCT03081494 (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 Novartis Pharmaceuticals
- Last refreshed: 11 December 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/NCT03081494.
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