Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Participants will receive escalating doses of emactuzumab along with atezolizumab every 3 weeks (q3w).

Participants will receive emactuzumab at or below the MTDs for the combination treatments that are determined during Part 1 along with atezolizumab.

Participants will receive atezolizumab intravenously at a fixed dose of 1200 milligram (mg) q3w.

Participants will receive emactuzumab intravenously in ascending dose levels with a starting dose of 500 mg.

Emactuzumab

Clinical Trials

This Phase 1, open-label, multicenter, global study will evaluate the safety, pharmacokinetics, and activity of emactuzumab and atezolizumab administered in combination in participants with selected locally advanced or metastatic solid tumors that are not amenable to standard treatment.

Participants who receive emactuzumab and atezolizumab will continue to receive study drug as long as they experience clinical benefit in the opinion of the investigator or until unacceptable toxicity or symptomatic deterioration attributed to disease progression as determined by the investigator after an integrated assessment of radiographic data, biopsy results (if available), and clinical status, or withdrawal of consent.

A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors

Open-Label, Multicenter, Dose Escalation Phase Ib Study With Expansion Phase to Evaluate the Safety, Pharmacokinetics, and Activity of RO5509554 (Emactuzumab) and MPDL3280A (Atezolizumab) Administered in Combination in Patients With Advanced Solid Tumors

predose (-4 hours \[h\]) and 0.5h post end of infusion (90 minutes infusion) on Days (D) 1 of Cycle (C) 1, 2, 3, 4, 5, 6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D15 of C1, C2, C4; D12, D19 of C1, C4; 44 and 120 days post last infusion; 28 day follow-up visit (up to approximately 3 years)

predose (-4 h) and 0.5h post end of infusion (90 minutes infusion) on D1 of C1, C2, C3, C4, C5, C6, all subsequent cycles (Cycle Length=21 days) until disease progression (up to approximately 3 years); 5h postdose on D1 of C1; postdose on D2, D4 or D5, D8, D15 of C1, C2, C4; D12, D19 of C1, C4; 44 and 120 days post last infusion; 28 day follow-up visit (up to approximately 3 years)

Baseline (predose \[-4 h\] on D1 of C1), predose \[-4 h\] on D1 of C2, C3, C5, then every other cycle (Cycle Length=21 days) until disease progression (up to approximately 3 years); postdose on D2, D8, D15 of C1, C2; D4 or D5 of C1; 44 days post last infusion (up to approximately 3 years)

Hoffmann-La Roche

Musculoskeletal Diseases

All Conditions

Neoplasms

Skin and Connective Tissue Diseases

Wounds and Injuries

Nervous System Diseases

Rare Diseases

Synovitis

Giant Cell Tumors

Giant Cell Tumor of Tendon Sheath

Synovitis, Pigmented Villonodular

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Joint Diseases

Tendinopathy

Muscular Diseases

Pigmented Villonodular Synovitis

Group 1: Subjects receiving emactuzumab administered on Day(D)1 and repeated once every two weeks (Q2W) for a total of 5 times, followed by an observation period of 3 months leading to a total period of 24 weeks in Part 1 and continued with a follow-up phase in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances

Group 2: Subjects receiving placebo administered as iv infusion on D1 and repeated once every two weeks (Q2W) for 5 times followed by an observation period of 3 months to a total period of 24 weeks in Part 1 will have the option to crossover under certain circumstances to open-label emactuzumab once every 2 weeks (Q2W) for a total of 5 times in Part 2.

Emactuzumab administered once every 2 weeks (q2w)

Matching placebo administered once every 2 weeks (q2w)

Placebo

Clinical Team Synox

Jean Y Blay, Prof, MD

This is a multicenter, Phase 3, randomised, double-blind, placebo-controlled study, which aims to evaluate the efficacy and safety of the investigational drug emactuzumab for the treatment of patients with localized or diffuse TGCT where surgical removal of the tumor is not viewed as an option.

The study consists of two parts. In Part 1, eligible subjects will be assigned in a 2:1 ratio to receive either emactuzumab or matching placebo in a double-blind fashion, that will be administered in total 5 times as an intravenous (i.v.) infusion once every 2 weeks. This will be followed by an observation period of 3 months leading to a total duration of 24 weeks in Part 1. A number of assessments will be carried out during the course of the study, including physical examinations, blood tests, imaging studies, electrocardiograms, and questionnaires. Part 2 is a long-term double-blind follow-up phase of the subjects on emactuzumab or placebo. Subjects assigned to placebo in Part 1 have the option to crossover under certain circumstances to receive open-label emactuzumab in Part 2. Subjects assigned to active drug in Part 1 have the option to receive open-label retreatment under certain circumstances.

Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)

A Phase III, Multicentre, Randomised, Double-Blind Study to Assess the Safety and Efficacy of Emactuzumab vs. Placebo in Subjects With Tenosynovial Giant Cell Tumour

Objective Response Rate (ORR = complete response \[CR\] + partial response \[PR\]) by 6 months from initiation of therapy according to RECIST v1.1 based on independent, blinded central review

Change in Patient-Reported Outcomes Measurement Information System Physical Function (PROMIS-PF) TGCT from baseline to 6 months

Mean change from baseline in active ROM of the joint over time

Mean change from baseline in the Worst Stiffness Numeric Rating Scale (NRS) score over time

Mean change in Pain Numerical Rating Scale (NRS) from baseline over time

Change in EuroQol 5-dimension, 5-level questionnaire (EQ-5D-5L)

Duration of response (DoR) as measured by RECIST version 1.1

SynOx Therapeutics Limited

Symptoms and General Pathology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Carcinoma

Adenocarcinoma

Recurrence

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Carcinoma, Transitional Cell

Cystadenocarcinoma, Serous

Adenocarcinoma, Clear Cell

Adenocarcinoma, Mucinous

Cystadenocarcinoma

Brenner Tumor

Carcinoma, Endometrioid

Neoplasms, Glandular and Epithelial

Disease Attributes

Ovarian Diseases

Adnexal Diseases

Genital Diseases, Female

Genital Diseases

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Genital Neoplasms, Female

Urogenital Neoplasms

Endocrine System Diseases

Gonadal Disorders

Neoplasms, Cystic, Mucinous, and Serous

Endometrial Neoplasms

Uterine Neoplasms

Neoplasms, Fibrous Tissue

Ovarian Cancer

Ovarian Epithelial Cancer

Transitional Cell Carcinoma

Fallopian Tube Cancer

Adenocarcinoma of the Appendix

Brenner Tumor of Ovary

Antibodies

Antibodies, Monoclonal

Paclitaxel

Bevacizumab

Albumin-Bound Paclitaxel

Immunoglobulins

Immunoglobulin G

Endothelial Growth Factors

Mitogens

Immunoglobulins, Intravenous

Tubulin Modulators

Antimitotic Agents

Angiogenesis Inhibitors

Growth Inhibitors

Immunologic Factors

Patients receive paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 and bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Patients receive paclitaxel and bevacizumab as in Arm I. Patients also receive emactuzumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

Laboratory Biomarker Analysis

Pharmacological Study

Anil K. Sood, MD

This randomized phase II trial studies the side effects of paclitaxel and bevacizumab with or without emactuzumab and how well they work in treating patients with ovarian, fallopian tube, or primary peritoneal cancer that has come back after treatment with platinum chemotherapy. Monoclonal antibodies, such as emactuzumab, block tumor growth in different ways by targeting certain cells. Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bevacizumab may prevent the growth of new blood vessels that tumors need to grow. Giving emactuzumab with paclitaxel and bevacizumab may work better in treating ovarian, fallopian tube, or primary peritoneal cancer.

PRIMARY OBJECTIVES:

I. To evaluate the safety of administration of paclitaxel, bevacizumab and emactuzumab over 4 weeks. (Part 1) II. To compare the progression-free survival (PFS) of patients with stable disease following Part 2A randomized to paclitaxel plus bevacizumab or to paclitaxel, bevacizumab plus emactuzumab. (Part 2B)

SECONDARY OBJECTIVES:

I. To estimate the progression-free survival (PFS) of the treatment arms. II. Objective response rate (ORR) by Response Evaluation Criteria in Solid Tumors (RECIST) and CA-125 response criteria ("responders").

III. Objective response rate by RECIST only ("RECIST responders"). IV. Objective response rate by CA-125 response criteria only ("CA-125 responders").

V. Biological progression-free interval (PFIbio) by serum CA-125 assessed according to the Gynecologic Cancer Intergroup (GCIG) criteria.

VI. Overall survival (OS). VII. Safety and tolerability. VIII. To characterize the pharmacokinetics of bevacizumab and emactuzumab when administered in combination.

EXPLORATORY OBJECTIVES:

I. To assess the utility of surrogate biomarkers and the anti-tumor response to therapy with the combination treatment of bevacizumab and emactuzumab.

II. To assess tumor alterations by serial non-invasive imaging macrophage-specific imaging, ADC (apparent diffusion coefficient) for cellularity, and DCE (dynamic contrast enhanced) for vasculature.

OUTLINE:

Patients receive paclitaxel intravenously (IV) over 60 minutes on days 1, 8, 15, and 22 and bevacizumab IV over 90 minutes on days 1 and 15. Treatment repeats every 28 days for up to 2 courses in the absence of disease progression or unexpected toxicity. Patients with stable disease are randomized to 1 of 2 arms.

ARM I: Patients receive paclitaxel IV over 60 minutes on days 1, 8, 15, and 22 and bevacizumab IV over 90 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive paclitaxel and bevacizumab as in Arm I. Patients also receive emactuzumab IV over 30 minutes on days 1 and 15. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 3 months for 2 years, every 4 months for 1 year, and then every 6 months for 2 years.

Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

A Randomized Phase II Induction Discontinuation Trial of Emactuzumab Following Paclitaxel and Bevacizumab in Patients With Platinum-Resistant, Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Safety is defined as no required dose alterations during the first cycle (4 weeks) of therapy due to a grade 3 or greater related adverse event.

National Cancer Institute (NCI)

M.D. Anderson Cancer Center

The study was terminated early by the sponsor and the study objective was unable to be fully evaluated

Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15, and Emactuzumab 1000 mg IV on Days 1 \& 15 on a 28 day cycle

Safety Lead-In

Paclitaxel 80 mg/m2 IV given on Days 1, 8, 15, \& 22 plus Bevacizumab 10 mg/Kg IV on Days 1 \& 15 on a 28 day cycle

Induction Arm

Randomized Arm 1

Randomized Arm 2

Total

Age, Categorical

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

The study was terminated early by the sponsor

Dr. Anil Sood

The study was terminated early by the sponsor and no data was collected for the study objective was unable to be fully evaluated.

Part 1: To Evaluate the Safety of Administration of Paclitaxel, Bevacizumab and Emactuzumab Over 4 Weeks.

Part 2B: To Compare the Progression-free Survival (PFS) of Patients With Stable Disease Following Part 2A Randomized to Paclitaxel Plus Bevacizumab or to Paclitaxel, Bevacizumab Plus Emactuzumab.

Overall Study

Emactuzumab and RO7009789 will be administered intravenously (IV) at a starting dose of 500 milligrams (mg) for emactuzumab and 2 mg for RO7009789. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent.

Emactuzumab and RO7009789 will be administered IV at the maximum tolerated dose defined in Part I of the study. Treatment will continue as long as there is clinical benefit until unacceptable toxicity, symptomatic deterioration, or withdrawal of consent.

Emactuzumab will be administered IV every 3 weeks (every cycle) during Part I and every 3 or 6 weeks (every cycle or every other cycle) during Part II.

RO7009789 will be administered IV every 3 weeks (every cycle).

RO7009789

This is an open-label, multicenter study designed to assess the safety, pharmacokinetics, pharmacodynamics, and therapeutic activity of emactuzumab and RO7009789 administered in combination in participants with locally advanced or metastatic solid tumors that are not amenable to standard treatment. This study will be conducted in two parts: a dose-finding stage (Part I) and an expansion stage (Part II).

A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors

An Open-Label, Multicenter, Dose-Escalation Phase Ib Study With Expansion Phase to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, and Therapeutic Activity of Emactuzumab and RO7009789 Administered in Combination in Patients With Advanced Solid Tumors

PrD (0 H), end of infusion (EOI) (infusion = 90 minutes \[min\]), postdose \[5 H\] D1 of C1/C4 (cycle = 3 weeks); on D2, 5, 8, 12, 15, 19 of C1/C4; on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)

PrD (0 H), EOI (infusion = 90 min), postdose \[5 H\] D1 of C1/C4; on D2, 5, 8, 12, 15, 19 of C1/C4 (cycle = 3 weeks); on D5, 8, 12, 17 of C2; on D2, 8, 15 of C3; PrD (0 H), EOI on D1 of C2, 3, 5 onwards until/at PD (up to 2 years); at 28, 44, 120 days after last dose (up to 2 years overall)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors	NCT02323191	Solid Cancers	Atezolizumab Emactuzumab	18 Years -	Hoffmann-La Roche
Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)	NCT05417789	TGCT	Emactuzumab Placebo	12 Years -	SynOx Therapeutics Limited
Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT02923739	Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Malignant Ovari... Ovarian Adenoca... Ovarian Clear C... Ovarian Endomet... Ovarian Mucinou... Ovarian Seromuc... Ovarian Serous ... Ovarian Transit... Ovarian Undiffe... Primary Periton... Recurrent Fallo... Recurrent Ovari... Recurrent Prima...	Bevacizumab Emactuzumab Laboratory Biom... Paclitaxel Pharmacological...	18 Years -	M.D. Anderson Cancer Center
A Study of Emactuzumab and Atezolizumab Administered in Combination in Participants With Advanced Solid Tumors	NCT02323191	Solid Cancers	Atezolizumab Emactuzumab	18 Years -	Hoffmann-La Roche
Paclitaxel and Bevacizumab With or Without Emactuzumab in Treating Patients With Platinum-Resistant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer	NCT02923739	Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Fallopian Tube ... Malignant Ovari... Ovarian Adenoca... Ovarian Clear C... Ovarian Endomet... Ovarian Mucinou... Ovarian Seromuc... Ovarian Serous ... Ovarian Transit... Ovarian Undiffe... Primary Periton... Recurrent Fallo... Recurrent Ovari... Recurrent Prima...	Bevacizumab Emactuzumab Laboratory Biom... Paclitaxel Pharmacological...	18 Years -	M.D. Anderson Cancer Center
A Study of Emactuzumab and RO7009789 Administered in Combination in Participants With Advanced Solid Tumors	NCT02760797	Neoplasms	Emactuzumab RO7009789	18 Years -	Hoffmann-La Roche
Study of Emactuzumab for Tenosynovial Giant Cell Tumor (TGCT)	NCT05417789	TGCT	Emactuzumab Placebo	12 Years -	SynOx Therapeutics Limited

Spots Global Cancer Trial Database for emactuzumab

Every month we try and update this database with for emactuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for emactuzumab

Every month we try and update this database with for emactuzumab cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for emactuzumab cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.