Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
A Prospective Phase I and II Trial of Ramucirumab + Pembrolizumab in Patients With Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma
Sponsor: Eli Lilly and Company
A observational or N/A phase clinical study on Head and Neck Squamous Cell Carcinoma, this trial is completed. The trial is conducted by Eli Lilly and Company and has accumulated 22 data snapshots since 2019. Oncology trials at this stage typically focus on safety, tolerability, and early efficacy signals.
Status Flow
Change History
22 versions recorded-
May 4, 2026 — Present [daily]
Completed
Status: Active Not Recruiting → Completed · Phase: PHASE1/PHASE2 → None
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Jan 2026 — May 2026 [monthly]
Active Not Recruiting PHASE1/PHASE2
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Sep 2025 — Jan 2026 [monthly]
Active Not Recruiting PHASE1/PHASE2
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Jan 2025 — Sep 2025 [monthly]
Active Not Recruiting PHASE1/PHASE2
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Sep 2024 — Jan 2025 [monthly]
Active Not Recruiting PHASE1/PHASE2
▶ Show 17 earlier versions
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Jul 2024 — Sep 2024 [monthly]
Active Not Recruiting PHASE1/PHASE2
Phase: PHASE1_PHASE2 → PHASE1/PHASE2
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Feb 2024 — Jul 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Sep 2023 — Feb 2024 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Jan 2023 — Sep 2023 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Sep 2022 — Jan 2023 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Dec 2021 — Sep 2022 [monthly]
Active Not Recruiting PHASE1_PHASE2
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Jun 2021 — Dec 2021 [monthly]
Active Not Recruiting PHASE1_PHASE2
Status: Recruiting → Active Not Recruiting
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Jan 2021 — Jun 2021 [monthly]
Recruiting PHASE1_PHASE2
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Jul 2020 — Jan 2021 [monthly]
Recruiting PHASE1_PHASE2
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Jan 2020 — Jul 2020 [monthly]
Recruiting PHASE1_PHASE2
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Sep 2019 — Jan 2020 [monthly]
Recruiting PHASE1_PHASE2
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Jul 2019 — Sep 2019 [monthly]
Recruiting PHASE1_PHASE2
Status: Not Yet Recruiting → Recruiting
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Jun 2019 — Jul 2019 [monthly]
Not Yet Recruiting PHASE1_PHASE2
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Mar 2019 — Jun 2019 [monthly]
Not Yet Recruiting PHASE1_PHASE2
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Jan 2019 — Mar 2019 [monthly]
Not Yet Recruiting PHASE1_PHASE2
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Nov 2018 — Jan 2019 [monthly]
Not Yet Recruiting PHASE1_PHASE2
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Sep 2018 — Nov 2018 [monthly]
Not Yet Recruiting PHASE1_PHASE2
First recorded
Eligibility Summary
The investigators hypothesize that inhibition of angiogenesis and PD-1 will be more effective than inhibition of PD-1 alone. The first step in pursuing proof of this hypothesis is to establish the safety and feasibility of combining ramucirumab with pembrolizumab, therefore the first part of this protocol is a de-escalation phase I trial of the combination of ramucirumab + pembrolizumab. The key objective of the phase I trial is to establish the safety and the recommended phase 2 dose (RP2D) of ramucirumab for this novel combination regimen in patients with recurrent/metastatic head and neck squamous cell carcinoma (RM-HNSCC). The second step in pursuing proof of this hypothesis is to establish the efficacy of ramucirumab (using the RP2D) with pembrolizumab. The second part of this protocol is a single arm phase II trial combining ramucirumab + pembrolizumab. The primary objective of the phase II trial is to determine the tumor response rates (complete response (CR) and partial response (PR)) of the treatment combination given as first line therapy in patients with RM-HNSCC.
Contact Information
- Eli Lilly and Company
- Washington University School of Medicine
For direct contact, visit the study record on ClinicalTrials.gov .