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Cited by 807

The DOI matches its Crossref record; 8 of the 8 references it cites were found in a registry or an index.

Phase I Study of Pembrolizumab (MK-3475; Anti–PD-1 Monoclonal Antibody) in Patients with Advanced Solid Tumors

Patnaik, Amita, Kang, S. Peter, Rasco, Drew, Papadopoulos, Kyriakos P., Elassaiss-Schaap, Jeroen, Beeram, Muralidhar, Drengler, Ronald, Chen, Cong, Smith, Lon, Espino, Guillermo, Gergich, Kevin, Delgado, Liliana, Daud, Adil, Lindia, Jill A., Li, Xiaoyun Nicole, Pierce, Robert H., Yearley, Jennifer H., Wu, Dianna, Laterza, Omar, Lehnert, Manfred, Iannone, Robert, Tolcher, Anthony W.·2015·Clinical Cancer Research
DOI 10.1158/1078-0432.ccr-14-2607
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Abstract

Purpose: This phase I study evaluated the safety, maximum tolerated dose, antitumor activity, and pharmacokinetics and pharmacodynamics of pembrolizumab in patients with advanced solid tumors. Experimental Design: In a 3 + 3 dose escalation study, 10 patients received pembrolizumab 1, 3, or 10 mg/kg intravenously every 2 weeks until progression or intolerable toxicity. Seven additional patients received 10 mg/kg every 2 weeks. Thirteen patients participated in a 3-week intrapatient dose escalation (dose range, 0.005–10 mg/kg) followed by 2 or 10 mg/kg every 3 weeks. Tumor response was assessed by Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1. Results: No dose-limiting toxicities were observed. Maximum administered dose was 10 mg/kg every 2 weeks. One patient with melanoma and one with Merkel cell carcinoma experienced complete responses of 57 and 56+ weeks' duration, respectively. Three patients with melanoma experienced partial responses. Fifteen patients with various malignancies experienced stable disease. One patient died of cryptococcal infection 92 days after pembrolizumab discontinuation, following prolonged corticosteroid use for grade 2 gastritis considered drug related. Pembrolizumab exhibited pharmacokinetic characteristics typical of humanized monoclonal antibodies. Maximum serum target engagement was reached with trough levels of doses greater than or equal to 1 mg/kg every 3 weeks. Mechanism-based translational models with a focus on intratumor exposure prediction suggested robust clinical activity would be observed at doses ≥2 mg/kg every 3 weeks. Conclusions: Pembrolizumab was well tolerated and associated with durable antitumor activity in multiple solid tumors. The lowest dose with full potential for antitumor activity was 2 mg/kg every 3 weeks. Clin Cancer Res; 21(19); 4286–93. ©2015 AACR. See related commentary by van Elsas et al., p. 4251

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Metadata

Authors
Patnaik, A., Kang, S. P., Rasco, D., Papadopoulos, K. P., Elassaiss-Schaap, J., Beeram, M., Drengler, R., Chen, C., Smith, L., Espino, G., Gergich, K., Delgado, L., Daud, A., Lindia, J. A., Li, X. N., Pierce, R. H., Yearley, J. H., Wu, D., Laterza, O., Lehnert, M., Iannone, R., & Tolcher, A. W.
Venue
Clinical Cancer Research
Publisher
American Association for Cancer Research (AACR)
Published
2015-09-30
Volume
21
Issue
19
Pages
4286-4293
ISSN
  • 1078-0432 (ISSN-L)
  • 1557-3265
DOI
10.1158/1078-0432.ccr-14-2607
OpenAlex
W2150048477
Cited by
807
References
8
FWCI
27.43
Type
journal article
Language
en
Open access
closed

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Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.