NCT03463460

Pembrolizumab and Sunitinib Malate in Treating Participants With Refractory Metastatic or Unresectable Thymic Cancer

Active, enrolled Phase 2 Last updated 23 March 2026

What this trial tests

Phase 2 trial testing Laboratory Biomarker Analysis in Thymic Carcinoma in 9 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

19 June 2018

Primary endpoint
30 April 2027

30 April 2027

Quick facts

Lead sponsor	Dwight Owen
Phase	Phase 2
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	9
Start date	19 June 2018
Primary completion	30 April 2027
Estimated completion	30 April 2027
Sites	3 locations across United States

Drugs / interventions tested

• Laboratory Biomarker Analysis — full drug profile →
• Pembrolizumab (pembrolizumab) — full drug profile →
• Sunitinib Malate (sunitinib-malate) — full drug profile →

Conditions studied

• Thymic Carcinoma — all drugs for Thymic Carcinoma →

Sponsor

Dwight Owen — full company profile →

Who can join

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

Sponsor's own description

This phase II trial studies how well pembrolizumab and sunitinib malate work in treating participants with thymic cancer that has spread to other places in the body or cannot be removed by surgery and does not respond to treatment. Monoclonal antibodies, such as pembrolizumab, may interfere with the ability of tumor cells to grow and spread. Sunitinib malate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Giving pembrolizumab and sunitinib malate may work better in treating thymic cancer.

Publications & conference data

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

1. Adverse Events of Concurrent Immune Checkpoint Inhibitors and Antiangiogenic Agents: A Systematic Review.
   Gao L, Yang X, Yi C, Zhu H. · · 2019 · cited 42× · PMID 31680957 · DOI 10.3389/fphar.2019.01173
2. Immune checkpoint inhibitors for treatment of thymic epithelial tumors: how to maximize benefit and optimize risk?
   Zhao C, Rajan A. · · 2019 · cited 34× · PMID 31608320 · DOI 10.21037/med.2019.08.02
3. Immunotherapy of thymic epithelial tumors: molecular understandings and clinical perspectives.
   Ao YQ, Gao J, Wang S, Jiang JH, et al · · 2023 · cited 32× · PMID 37055838 · DOI 10.1186/s12943-023-01772-4
4. Immunobiology of Thymic Epithelial Tumors: Implications for Immunotherapy with Immune Checkpoint Inhibitors.
   Tateo V, Manuzzi L, De Giglio A, Parisi C, et al · · 2020 · cited 31× · PMID 33260538 · DOI 10.3390/ijms21239056
5. Trial Watch: combination of tyrosine kinase inhibitors (TKIs) and immunotherapy.
   Petrazzuolo A, Maiuri MC, Zitvogel L, Kroemer G, et al · · 2022 · cited 23× · PMID 35655707 · DOI 10.1080/2162402x.2022.2077898
6. Immunotherapy for thymoma.
   Jakopovic M, Bitar L, Seiwerth F, Marusic A, et al · · 2020 · cited 22× · PMID 33447455 · DOI 10.21037/jtd-2019-thym-12
7. Overcoming physical stromal barriers to cancer immunotherapy.
   Chung SW, Xie Y, Suk JS. · · 2021 · cited 20× · PMID 34351575 · DOI 10.1007/s13346-021-01036-y
8. Immunotherapy for Management of Thymic Epithelial Tumors: A Double-Edged Sword.
   Ballman M, Zhao C, McAdams MJ, Rajan A. · · 2022 · cited 16× · PMID 35565190 · DOI 10.3390/cancers14092060