Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Endometrial Neoplasms

Uterine Neoplasms

Genital Neoplasms, Female

Urogenital Neoplasms

Uterine Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Antineoplastic Agents

All Drugs and Chemicals

Pharmaceutical Solutions

Natriuretic Agents

Gastrointestinal Agents

Bone Density Conservation Agents

Central Nervous System Depressants

Other Dietary Supplements

Lenvatinib

Pembrolizumab

Calcium

Mannitol

Calcium Carbonate

Calcium, Dietary

Benzocaine

Antineoplastic Agents, Immunological

Immune Checkpoint Inhibitors

Protein Kinase Inhibitors

Enzyme Inhibitors

Tannic Acid

3 to 6 patients will receive EG-007 1000 mg once weekly starting on the day of injection of Pembrolizimab starting the next 21-day cycle of treatment.

6 to 10 patients will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab under this protocol.

6 to 12 patients initiating new regimens of Len+Pem will receive EG-007 loading dose of 5000 mg given as 1000 mg daily over 5 consecutive days starting 4 days before the first dose of Pembrolizumab.

EG-007

Pembrolizumab will be provided as a sterile, preservative-free, clear to slightly opalescent, colorless to slightly yellow solution that requires dilution for intravenous infusion. Each vial contains 100 mg of pembrolizumab in 4 mL of solution.

Pembrolizumab 100 mg/4 mL (25 mg/ml) Injection

Lenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropyl cellulose, low-substituted hydroxypropylcellulose, and talc.

Lenvatinib Capsules

Xin Du, Ph.D.

Charles Lee, M.D., Ph.D.

This is a Phase 2 trial Safety Lead-in trial conducted in 3 cohorts of patients.

A safety lead-in study of the impact of adding the Repurposed Drugs a third agent will be conducted prior to opening enrollment into the compassionate use study. All patients enrolled in the safety lead-in study may continue long-term treatment under this protocol without interruption of dosing.

Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem

A Phase 2, Open-Label, Safety Lead-In With Long Term Safety Study of EG-007, Added to the Combination of Lenvatinib Plus Pembrolizumab

Number of Participants With Treatment-Related Adverse Events as Assessed by NCI CTCAE v5.0, toxicities will be characterized in terms including seriousness, causality, toxicity grading, and action taken with regard to trial treatment. Data Monitoring committee review for safety to proceed through dose escalation.

Using NCI-PRO CTCAE to record the tolerability score for patients to evaluate symptomatic toxicities.

To conduct long-term monitoring of the safety and clinical outcomes for EG-007 plus Len+Pem. The proportion of Participants With Treatment-Related Adverse Events during long-term monitoring.

Evergreen Therapeutics, Inc.

Digestive System Diseases

Carcinoma

Carcinoma, Hepatocellular

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Adenocarcinoma

Liver Neoplasms

Gastrointestinal Neoplasms

Digestive System Neoplasms

Gastrointestinal Diseases

Liver Diseases

Bevacizumab

Atezolizumab

Single arm with Pembrolizumab 200 mg over 30 minutes IV infusion on Day 1 every 3 weeks until disease progression or inacceptable toxicity or end of study treatment. Lenvatinib 8 mg for a body weight \< 60 kg and 12 mg for a body weight ≥ 60 kg orally continuously once daily, starting on Day 1 of every 3 week cycle until disease progression or inacceptable toxicity or end of study treatment.

Pembrolizumab 200 mg, IV, over 30 minutes every 3 weeks

Lenvatinib 8 mg for BW \< 60 kg / 12 mg for BW ≥ 60 kg oral, once daily for 3 weeks

Salah-Eddin Al-Batran, Prof. Dr.

Arndt Vogel, Prof. Dr.

Patients with advanced HCC, refractory to atezolizumab and bevacizumab /IO-based therapy will be treated with pembrolizumab and lenvatinib. Efficacy of the combination therapy will be assessed by objective reponse rate, progression free survival, overal survival, safety/tolerability.

This is a multicenter, single arm, open-label phase II trial investigating the clinical activity of a second-line therapy with the anti-PD-1 antibody pembrolizumab (200 mg IV, q3w) and the multiple receptor tyrosine kinase inhibitor (TKI) lenvatinib (8 mg for BW \< 60 kg / 12 mg for BW ≥ 60 kg p.o. QD) in advanced HCC patients who are refractory to atezolizumab and bevacizumab/ IO-based therapy.

The primary objective is to assess the efficacy by objective response rate (ORR) according to RECIST 1.1 criteria.

Secondary objectives are to determine efficacy in terms of progression free survival (PFS), overall survival (OS) as well as safety and toxicity (acc. to NCI-CTC V5.0).

In addition, tissue and serum samples (optional) will be analyzed for molecular biomarkers predictive for ORR, PFS and OS.

32 patients will be enrolled in this trial.

Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy

A Phase-II Open-label Study of Pembrolizumab and Lenvatinib in Patients With Advanced Stage Hepatocellular Carcinoma Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy

ORR, defined as the percentage of patients with complete response (CR) or partial response (PR) according to RECIST 1.1.

PFS, defined as time from first dose of study treatment to date of first observed disease progression according to RECIST 1.1 or death from any cause.

OS, defined as time from first dose of study treatment to the date of death of any cause.

Adverse events will be recorded and graded according to NCI-CTC V5.0. Occurrence of (Serious) Adverse Events at any time during the study. Description by nature (Primary System Organ Class and Preferred Term), severity and causal relationship to drug administration.

Medizinische Hochschule Hannover, Germany, Prof. Dr. Arndt Vogel

Merck Sharp & Dohme LLC

Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest

Pembrolizumab 100 mg/ 4 ml (25 mg/ml) Injection

Lenvatinib will be provided as 4-mg and 10-mg capsules. Lenvatinib is formulated with calcium carbonate, mannitol, microcrystalline cellulose, hydroxypropylcellulose, low-substituted hydroxypropylcellulose, and talc.

This is a Phase 3, multicenter, randomized, open-label trial to evaluate whether EG-007 plus Len+Pem is superior to Len+Pem alone in patients with advanced endometrial cancer (Stage III or IV). This trial will be preceded by a safety lead-in study with up to 28 patients (the safety lead-in is a separate, free-standing protocol).

Approximately 450 patients will be randomized equally (1:1) to receive EG-007 plus Len+Pem or Len+Pem alone. The randomization will be stratified by the following stratification factors:

* Diagnosis Classification (advanced Stage III/IV vs. recurrent endometrial cancer)
* ECOG score at baseline (0 vs 1)
* Geographic region (Asia vs ROW)

Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer

A Phase 3, Randomized, Open-Label, Active-Controlled, Superiority Trial of EG007, Added to the Combination of Lenvatinib Plus Pembrolizumab vs. Lenvatinib Plus Pembrolizumab in Patients With Advanced Endometrial Cancer

Progression-free survival (PFS) by RECIST v1.1 treatment vs. control group

Objective Response Rate (ORR) treatment vs. control group

Overall survival (OS) treatment vs. control group

Duration of response (DOR) treatment vs. control group

Disease control rate (DCR: CR + PR + stable disease \[SD\]) treatment vs. control group

Durable stable disease rate (durable SD \[SD ≥23 weeks\]) treatment vs. control group

Clinical benefit rate (CBR: CR, PR + durable SD) treatment vs. control group

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem	NCT05106127	Advanced Endome...	EG-007 Pembrolizumab 1... Lenvatinib Caps...	18 Years -	Evergreen Therapeutics, Inc.
Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy	NCT05101629	Hepatocellular ...	Pembrolizumab Lenvatinib Caps...	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Pembrolizumab and Lenvatinib in Patients With Advanced HCC Who Are Refractory to Atezolizumab and Bevacizumab/ IO-based Therapy	NCT05101629	Hepatocellular ...	Pembrolizumab Lenvatinib Caps...	18 Years -	Institut für Klinische Krebsforschung IKF GmbH at Krankenhaus Nordwest
Efficacy and Safety of a Repurposed Drug Added to the Combination of Len Plus Pem in Advanced Endometrial Cancer	NCT05077215	Advanced Endome...	EG-007 Pembrolizumab 1... Lenvatinib Caps...	18 Years -	Evergreen Therapeutics, Inc.
Safety Lead-In Study of a Repurposed Drug Added to the Combination of Len Plus Pem	NCT05106127	Advanced Endome...	EG-007 Pembrolizumab 1... Lenvatinib Caps...	18 Years -	Evergreen Therapeutics, Inc.

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