NCT02890069

A Study of PDR001 in Combination With LCL161, Everolimus or Panobinostat

Completed Phase 1 Last updated 11 January 2023

What this trial tests

Phase 1 trial testing PDR001 in Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma in 298 participants. Completed in 22 February 2022.

Timeline

14 October 2016

Primary endpoint
22 February 2022

22 February 2022

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 1
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	298
Start date	14 October 2016
Primary completion	22 February 2022
Estimated completion	22 February 2022
Sites	25 locations across Netherlands, Taiwan, United Kingdom, Germany, South Korea, United States, Spain

Drugs / interventions tested

• PDR001
• LCL161 — full drug profile →
• Everolimus (everolimus) — full drug profile →
• Panobinostat (PANOBINOSTAT) — full drug profile →
• QBM076 — full drug profile →
• HDM201

Conditions studied

• Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma — all drugs for Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Colorectal Cancer, Non-small Cell Lung Carcinoma (Adenocarcinoma), Triple Negative Breast Cancer, Renal Cell Carcinoma. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The purpose of this study was to combine the PDR001 checkpoint inhibitor with several agents with immunomodulatory activity to identify the doses and schedule for combination therapy and to preliminarily assess the safety, tolerability, pharmacological and clinical activity of these combinations.

Publications & conference data

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

1. PD-1 and PD-L1 Checkpoint Signaling Inhibition for Cancer Immunotherapy: Mechanism, Combinations, and Clinical Outcome.
   Alsaab HO, Sau S, Alzhrani R, Tatiparti K, et al · · 2017 · cited 1206× · PMID 28878676 · DOI 10.3389/fphar.2017.00561
2. Targeting transcription factors in cancer - from undruggable to reality.
   Bushweller JH. · · 2019 · cited 741× · PMID 31511663 · DOI 10.1038/s41568-019-0196-7
3. Targeting p53 pathways: mechanisms, structures, and advances in therapy.
   Wang H, Guo M, Wei H, Chen Y. · · 2023 · cited 580× · PMID 36859359 · DOI 10.1038/s41392-023-01347-1
4. Recent advances in targeting the "undruggable" proteins: from drug discovery to clinical trials.
   Xie X, Yu T, Li X, Zhang N, et al · · 2023 · cited 246× · PMID 37669923 · DOI 10.1038/s41392-023-01589-z
5. The Role of p53 Signaling in Colorectal Cancer.
   Liebl MC, Hofmann TG. · · 2021 · cited 231× · PMID 33924934 · DOI 10.3390/cancers13092125
6. Warburg effect in colorectal cancer: the emerging roles in tumor microenvironment and therapeutic implications.
   Zhong X, He X, Wang Y, Hu Z, et al · · 2022 · cited 223× · PMID 36319992 · DOI 10.1186/s13045-022-01358-5
7. Ubiquitination and deubiquitination in cancer: from mechanisms to novel therapeutic approaches.
   Liu F, Chen J, Li K, Li H, et al · · 2024 · cited 195× · PMID 39048965 · DOI 10.1186/s12943-024-02046-3
8. Immunotherapy in Renal Cell Carcinoma: The Future Is Now.
   Deleuze A, Saout J, Dugay F, Peyronnet B, et al · · 2020 · cited 178× · PMID 32260578 · DOI 10.3390/ijms21072532