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NCT02303990

RADVAX: A Stratified Phase I Trial of Pembrolizumab With Hypofractionated Radiotherapy in Patients With Advanced and Metastatic Cancers

Completed Phase 1 Results posted Last updated 23 April 2021
What this trial tests

Phase 1 trial testing Pembrolizumab in Metastatic Cancers in 59 participants. Completed in 31 December 2019.

Timeline
8 January 2015
Primary endpoint
1 December 2018
31 December 2019

Quick facts

Lead sponsorAbramson Cancer Center at Penn Medicine
PhasePhase 1
StatusCompleted
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposetreatment
Enrollment59
Start date8 January 2015
Primary completion1 December 2018
Estimated completion31 December 2019
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Abramson Cancer Center at Penn Medicine — full company profile →

Who can join

18 and older, any sex, with Metastatic Cancers. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

Phase I clinical trial of hypofractionated radiotherapy to an isolated index lesion in combination with the PD-1 inhibitor, Pembrolizumab in patients with metastatic cancers who have failed anti-PD-1 therapy (melanoma and NSCLC) and patients with metastatic cancers who have have progressed after at least one regimen of systemic therapy (breast, pancreas, and other).

Publications & conference data

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

  1. Challenges and Opportunities for Pancreatic Cancer Immunotherapy.
    Bear AS, Vonderheide RH, O'Hara MH. · · 2020 · cited 500× · PMID 32946773 · DOI 10.1016/j.ccell.2020.08.004
  2. Improvement of the anticancer efficacy of PD-1/PD-L1 blockade via combination therapy and PD-L1 regulation.
    Wu M, Huang Q, Xie Y, Wu X, et al · · 2022 · cited 336× · PMID 35279217 · DOI 10.1186/s13045-022-01242-2
  3. Current clinical trials testing the combination of immunotherapy with radiotherapy.
    Kang J, Demaria S, Formenti S. · · 2016 · cited 293× · PMID 27660705 · DOI 10.1186/s40425-016-0156-7
  4. Targeting immune checkpoints in breast cancer: an update of early results.
    Solinas C, Gombos A, Latifyan S, Piccart-Gebhart M, et al · · 2017 · cited 122× · PMID 29177095 · DOI 10.1136/esmoopen-2017-000255
  5. The Abscopal Effect of Radiation Therapy: What Is It and How Can We Use It in Breast Cancer?
    Hu ZI, McArthur HL, Ho AY. · · 2017 · cited 115× · PMID 28344743 · DOI 10.1007/s12609-017-0234-y
  6. The clinical promise of immunotherapy in triple-negative breast cancer.
    Vikas P, Borcherding N, Zhang W. · · 2018 · cited 111× · PMID 30573992 · DOI 10.2147/cmar.s185176
  7. Radiation-induced neoantigens broaden the immunotherapeutic window of cancers with low mutational loads.
    Lussier DM, Alspach E, Ward JP, Miceli AP, et al · · 2021 · cited 109× · PMID 34099555 · DOI 10.1073/pnas.2102611118
  8. Combination of immunotherapy with chemotherapy and radiotherapy in lung cancer: is this the beginning of the end for cancer?
    Lazzari C, Karachaliou N, Bulotta A, Viganó M, et al · · 2018 · cited 91× · PMID 29662546 · DOI 10.1177/1758835918762094

Verify or expand the search:

Other trials of Pembrolizumab

Trials testing the same drug.

Other recruiting trials for Metastatic Cancers

Currently open trials in the same condition.

Other Abramson Cancer Center at Penn Medicine trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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/NCT02303990.

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