Neoplasms

Respiratory Tract (Lung and Bronchial) Diseases

All Conditions

Rare Diseases

Small Cell Lung Carcinoma

Lung Neoplasms

Carcinoma

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Carcinoma, Bronchogenic

Bronchial Neoplasms

Small Cell Lung Cancer

Antineoplastic Agents

All Drugs and Chemicals

Carboplatin

Etoposide

Cisplatin

Etoposide phosphate

Enzyme Inhibitors

OMP-59R5

Placebo

Cisplatin or Carboplatin

The study consists of a Phase1b lead-in portion to determine the maximum tolerated dose (MTD) of OMP-59R5 (tarextumab) in combination with etoposide (EP) for 6 cycles followed a Phase 2, multi center, randomized, placebo-controlled portion comparing the efficacy and safety of OMP-59R5 in combination with EP for 6 cycles followed by single agent OMP-59R5 relative to EP alone for 6 cycles in subjects receiving first-line therapy for extensive stage small cell lung cancer.

The Phase 1b lead-in portion of the study was conducted to determine the MTD of OMP-59R5 administered along with EP. The Phase 2 portion of the study was multi-center, randomized, and placebo-controlled. Subjects who qualified for enrollment into the Phase 2 portion of the study were randomized in a 1:1 ratio to receive study treatment of tarextumab along with EP (Arm A) or placebo along with EP (Arm B).

A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy

A Phase 1b/2 Study of OMP-59R5 in Combination With Etoposide and Platinum Therapy in Subjects With Untreated Extensive Stage Small Cell Lung Cancer (PINNACLE)

To determine the MTD of tarextumab when administered on Day 1 of each 21 day cycle along with etoposide 100 mg/m2 on Days 1, 2 and 3, and cisplatin 80 mg/m2 or carboplatin area under the curve (AUC) of 5 mg/mL•min on Day 1 in subjects with untreated extensive stage small cell lung cancer. DLT evaluable population includes all subjects who received at least 1 partial dose of OMP-59R5 during the Phase 1b dose escalation portion of the study including the carboplatin cohort and who had completed Day 21 cycle of 1 OMP-59R5 administration or had discontinued due to drug-related toxicity.

The best overall response is defined as the best Investigator-assessed response recorded from the start of the treatment until disease progression in the following order of importance: Complete Response (CR), Partial Response (PR), Stable Disease (SD), Progressive Disease (PD), Not Evaluable (NE). Response evaluable population includes subjects who received 1 partial dose of OMP-59R5 and at at least 1 post tumor assessment.

To determine the improvement in Progression Free Survival (PFS) resulting from the addition of tarextumab to etoposide and platinum therapy (EP) in subjects receiving first-line therapy for extensive stage small cell lung cancer. PFS is based on the Investigator-assessments of tumor response which is defined as the number of days from randomization until death or disease progression as defined by RECIST criteria for the ITT Population.

The response rate is the number of subjects per treatment arm who have either a complete response (CR) or partial response (PR) for best overall response (according to RECIST criteria) divided by the number of subjects randomized to the respective arms.

OncoMed Pharmaceuticals, Inc.

P1: All cause mortality was assessed on the ITT population which was comprised of all subjects who receive at least one partial dose of OMP-59R5. Serious and non-serious AEs were assessed on the ITT population.

P2: All cause mortality was assessed on the ITT population which was comprised of all randomized subjects. Serious and non-serious AEs were assessed on the Safety Population which was defined as all subjects who received one partial dose of OMP-59R5 or placebo.

Cohort 1: Subjects receive OMP-59R5 5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).

P1B: OMP-59R5 5mg/kg + ETO + CIS

Cohort 2: Subjects receive OMP-59R5 7.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).

P1B: OMP-59R5 7.5 mg/kg + ETO + CIS

Cohort 3: Subjects receive OMP-59R5 10 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3 and cisplatin 80 mg/m2 on Day 1).

P1B: OMP-59R5 10 mg/kg + ETO + CIS

Cohort 4: Subjects receive OMP-59R5 12.5 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).

P1B: OMP-59R5 12.5 mg/kg + ETO + CIS

Cohort 5: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and cisplatin 80 mg/m2 (Day 1).

P1B: OMP-59R5 15 mg/kg + ETO + CIS

Cohort 6: Subjects receive OMP-59R5 15 mg/kg (administered on Day 1 of each 21-day cycle) along with etoposide 100 mg/m2 (Days 1, 2, and 3) and carboplatin AUC of 5 mg/mL•min (Day 1).

P1B: OMP-59R5 15mg/kg + ETO + CARB

Placebo Arm: Active Arm: Subjects receive placebo and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg \*min

P2: Placebo + CIS or CARB

Active Arm: Subjects receive OMP-59R5 15 mg/kg and etoposide 100 mg/m2 and cisplatin 75 mg/m2 or carboplatin AUC 5 mg/kg \*min

P2: OMP-59R5 15 mg/kg + ETO and CIS or CARB

Total

Age, Customized

Sex: Female, Male

Race (NIH/OMB)

United States

Region of Enrollment

Manager, Regulatory Affairs

The MTD of OMP-59R5 in combination with etoposide and cisplatin or carboplatin was not reached and the recommended phase 2 dose was determined to be 15 mg/kg every 21-day cycle.

Phase 1b: To Determine the Maximum Tolerated Dose (MTD) of OMP-59R5 When Administered With Etoposide and Cisplatin or Carboplatin (Number of Subjects With DLTs)

Phase 1b: Overall Response (Response Evaluable Population)

Phase 2: Progression Free Survival (ITT Population)

Phase 2: Best Overall Tumor Response Based on Investigator Assessment (ITT Population)

Overall Study

Skin and Connective Tissue Diseases

Melanoma

Carcinoma, Non-Small-Cell Lung

Neuroendocrine Tumors

Neuroectodermal Tumors

Neuroectodermal Tumors, Primitive

Neoplasms, Germ Cell and Embryonal

Neoplasms by Histologic Type

Neoplasms, Nerve Tissue

Nevus, Pigmented

Nevus

Nevi and Melanomas

Skin Neoplasms

Skin Diseases

Neuroendocrine Tumor

Neuroepithelioma

Immunomodulating Agents

Patients with newly diagnosed stage IV NSCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.

Patients with NSCLC stage IV treated with Immunotherapy at 2nd line or consecutive lines.

Patients with stage IV malignant melanoma treated with Immunotherapy with or without targeted therapy.

Patients with stage IIIb-d malignant melanoma treated with Immunotherapy as adjuvant therapy.

Patients with stage IV SCLC treated with Immunotherapy or Immunotherapy + Chemotherapy.

Plasma sample collection

Shani Raveh Shoval, Ph.D.

Davika Das, MD

Yanyan Lou, MD

Jose Lutzky, MD

Ernesto Bustinza, MD

Anthony Magliocco, MD

So Hyeon Park

Marina Messinger

Marina Messinger, MD

William Fusselman, MD

Adam Berger, MD

Igor Puzanov, MD

Noam VanderWalde, MD

Ari VanderWalde, MD

Anita Sabichi, MD

Sunil Patel, MD

Ina Koch, PhD

Marc Schneider, PhD

Petros Christopoulos, MD

Mahmud Abu-Amana, MD

Gil Bar-Sela, Prof.

Kamel Mahmid, MD

Olga Vornicova, MD

Tatiana Charkovsky, MD

Moshe Schaffer, MD

Raya Leibowitz-Amit, MD

Nirit Yarom, MD

Tatiana Nisimov, MD

Svetlana Kovel, MD

Adi Rasco, MD

Alona Zer, MD

Mira Wollner, MD

Talia Shentzer, MD

Michal Lotem, Prof.

Hovav Hovav Nechushtan, Prof.

Jonathan Cohen, MD

Yakir Rottenberg, MD

Avner Mordechay, MD

Maya Gottfried, MD

Natalie Maimon-Rabinovich, MD

Moshe Mishaly, MD

Mor Moskovitz, MD

Hendler Daniel, MD

Rivka Katsenelson, MD

Elizabeta Dudnik, MD

Ronnie Shapira, MD

Jair Bar, MD

Amir Onn, MD

Sameh Daher, MD

Akram Saad, MD

Shirley Grinberg, MD

Ronen Shtoff, MD

Smadar Bauer, MD

Tamar Beller, MD

David Vicente, MD

Gillian Price, MD

Tom Geldart, MD

Andrew Conn, MD

David Farrugia, MD

Alison Brewster, MD

Andreas Polychronis, MD

Anirban Chatterjee, MD

Adam Hassani, MD

Helen Cheley

Louise Medley, MD

Michal Lotem, MD

Abed Agbaria, MD

Ido Wolf, MD

Alexander Yakobson, MD

Tatiana Harkovsky, MD

Raya Leibowitz, MD

Antony Magliocco, MD

Adam Hassani

Ronnie Shapira Frommer, MD

William P Fusselman, MD

David Vecente, MD

This study will develop an algorithm of identifying patients with stage IV NSCLC and Melanoma who could benefit from cancer treatment they receive.

The goal of this research study is to develop an algorithm that predicts the patient's treatment outcome.This algorithm will serve as a tool for physicians when making treatment decisions, specifically for stage IV NSCLC and malignant melanoma patients receiving anti-cancer treatments. The investigators also aim to identify the metabolic pathways that could lead to better therapeutic options. The patients will be given their treatment according to the institute's standard of care. The patients will provide two blood samples and clinical data will be collected from their medical records.

In the first part of the trial, the data obtained from the blood samples and the medical records of the patients will be used to develop the prediction algorithm, and in the second part of the trial, the algorithm will be validated by comparing the objective response rate of the patients to the theoretical response prediction of the algorithm.

Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

PROPHETIC - Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments

Collect Progression Free Survival (PFS) dates

ORR as defined by RECIST 1.1 or other validated method for ORR evaluation

Changes in Blood levels of proteins representing the Host response

OncoHost Ltd.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy	NCT01859741	Stage IV Small ...	OMP-59R5 Etoposide Placebo Cisplatin or Ca...	18 Years - 90 Years	Mereo BioPharma
Predicting Responsiveness in Oncology Patients Based on Host Response Evaluation During Anti Cancer Treatments	NCT04056247	Stage IV Non-sm... Stage IV Malign... Stage IV Small ... Stage III Malig...	Plasma sample c...	18 Years -	OncoHost Ltd.
A Phase 1b/2 Study of OMP-59R5 (Tarextumab) in Combination With Etoposide and Platinum Therapy	NCT01859741	Stage IV Small ...	OMP-59R5 Etoposide Placebo Cisplatin or Ca...	18 Years - 90 Years	Mereo BioPharma

Spots Global Cancer Trial Database for stage iv small cell lung cancer