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Safety, Preliminary Efficacy and PK of Isatuximab (SAR650984) Alone or in Combination With Atezolizumab in Patients With Advanced Malignancies

Study Purpose

Primary Objectives:

  • - Phase 1: To characterize the safety and tolerability of isatuximab in combination with atezolizumab in participants with unresectable hepatocellular carcinoma (HCC), platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (SCCHN), platinum-resistant/refractory epithelial ovarian cancer (EOC), or recurrent glioblastoma multiforme (GBM), and to determine the recommended Phase 2 dose (RP2D).
  • - Phase 2: To assess response rate (RR) of isatuximab in combination with atezolizumab in participants with HCC or SCCHN or EOC.
  • - Phase 2: To assess the progression free survival rate at 6 months (PFS-6) of isatuximab in combination with atezolizumab, or as a single agent in participants with GBM.
Secondary Objectives:
  • - To evaluate the safety profile of isatuximab monotherapy (GBM only), or in combination with atezolizumab in Phase 2.
  • - To evaluate the immunogenicity of isatuximab and atezolizumab.
  • - To characterize the pharmacokinetic (PK) profile of isatuximab single agent (GBM only) and atezolizumab in combination with isatuximab.
  • - To assess the overall efficacy of isatuximab in combination with atezolizumab, or single agent (GBM only).

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion criteria:

  • - Participants must have a known diagnosis of either unresectable HCC, platinum-refractory recurrent/metastatic SCCHN, platinum-resistant/refractory EOC with evidence of measurable disease or recurrent GBM.
  • - Greater than or equal to (>=)18 years of age.
  • - For participants with HCC: Documentation of progressive disease (PD) during or after treatment with either sorafenib or lenvatinib, or intolerance to the therapy.
  • - For participants with SCCHN: Received and failed up to 2 lines of prior systemic anti-cancer therapy with documentation of tumor recurrence or PD within 6 months of last platinum-based therapy in primary, recurrent, or metastatic setting.
  • - For participants with EOC: Received up to 3 lines of prior platinum-containing therapy when the disease was platinum-sensitive, and the participants should not have received any systemic therapy for platinum-resistant/refractory disease.
Specific to France only: Documentation of PD on or after 1 line of anti-cancer therapy for platinum resistant/refractory disease (unless participants are ineligible or intolerant to standard of care for platinum-resistant/refractory disease).
  • - For participants with GBM: Documentation of PD or first recurrence during or after temozolomide maintenance therapy for newly diagnosed GBM treated with 1st line radiotherapy plus concurrent temozolomide.

Exclusion criteria:

  • - Prior exposure to agent that blocks CD38 or participation in clinical studies with isatuximab.
  • - For participants with HCC, SCCHN, EOC or GBM prior exposure to any agent (approved or investigational) that blocks the PD-1/PD-L1 pathway.
  • - Evidence of other immune related disease /conditions.
  • - History of non-infectious pneumonitis requiring steroids or current pneumonitis; history of the thoracic radiation.
  • - Received a live-virus vaccination within 28 days of planned treatment start.
Seasonal flu vaccines that do not contain live virus are permitted.
  • - Prior solid organ or bone marrow transplantation.
  • - Eastern Cooperative Oncology Group performance status >=2 for participants with HCC, SCCHN or EOC or Karnofsky performance score less than or equal to (<=) 70 for participants with GBM.
  • - Poor bone marrow reserve.
  • - Poor organ function.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT03637764
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 1/Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 Sanofi
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Clinical Sciences & Operations
Principal Investigator Affiliation Sanofi
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Industry
Overall Status Terminated
Countries Belgium, Canada, Czechia, Italy, Netherlands, Spain, Taiwan, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Neoplasm
Additional Details

The total study duration per participant was up to 28 months including up to 28 days screening period, up to 24 months treatment period, and a 3 month safety follow up period.

Arms & Interventions

Arms

Experimental: Cohort A: HCC: Isatuximab + Atezolizumab

Participants with hepatocellular carcinoma (HCC) received atezolizumab 1200 milligrams, every 3 weeks (Q3W), intravenous (IV) infusion along with isatuximab 10 milligrams per kilogram (mg/kg), IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable adverse events (AE), participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 106 weeks).

Experimental: Cohort B: SCCHN: Isatuximab + Atezolizumab

Participants with squamous cell carcinoma of the head and neck (SCCHN) received atezolizumab 1200 milligrams,Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 108 weeks).

Experimental: Cohort C: EOC: Isatuximab + Atezolizumab

Participants with epithelial ovarian cancer (EOC) received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 61 weeks).

Experimental: Cohort D-1: GBM: Isatuximab + Atezolizumab

Participants with glioblastoma multiforme (GBM) received atezolizumab 1200 mg, Q3W, IV infusion along with isatuximab 10 mg/kg, IV infusion, once weekly for 3 weeks (i.e., on Day 1, Day 8 and Day 15 of Cycle 1) and then Q3W (i.e., on Day 1 of each 21- day treatment cycle) until disease progression, unacceptable AE, participant's decision to stop the treatment, or death or study cut-off whichever occurred first (maximum duration of exposure: 54 weeks).

Interventions

Drug: - Isatuximab SAR650984

Pharmaceutical form: solution for infusion Route of administration: intravenous

Drug: - Atezolizumab

Pharmaceutical form: solution for infusion Route of administration: intravenous

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Investigational Site Number :8400004, Santa Monica, California

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Investigational Site Number :8400004

Santa Monica, California, 90404

Investigational Site Number :8400007, Boston, Massachusetts

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Investigational Site Number :8400007

Boston, Massachusetts, 02115

Investigational Site Number :8400002, Houston, Texas

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Investigational Site Number :8400002

Houston, Texas, 77030

International Sites

Investigational Site Number :0560001, Bruxelles, Belgium

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Investigational Site Number :0560001

Bruxelles, , 1200

Investigational Site Number :0560002, Gent, Belgium

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Investigational Site Number :0560002

Gent, , 9000

Investigational Site Number :1240001, Toronto, Ontario, Canada

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Investigational Site Number :1240001

Toronto, Ontario, M5G 2M9

Investigational Site Number :2030001, Brno, Czechia

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Investigational Site Number :2030001

Brno, , 65653

Investigational Site Number :2030003, Olomouc, Czechia

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Investigational Site Number :2030003

Olomouc, , 77900

Investigational Site Number :2030002, Praha 2, Czechia

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Investigational Site Number :2030002

Praha 2, , 12808

Investigational Site Number :3800007, Meldola, Forlì-Cesena, Italy

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Investigational Site Number :3800007

Meldola, Forlì-Cesena, 47014

Investigational Site Number :3800003, Rozzano, Milano, Italy

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Investigational Site Number :3800003

Rozzano, Milano, 20089

Investigational Site Number :3800009, Milano, Italy

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Investigational Site Number :3800009

Milano, , 20141

Investigational Site Number :3800004, Padova, Italy

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Investigational Site Number :3800004

Padova, , 35128

Investigational Site Number :5280001, Rotterdam, Netherlands

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Investigational Site Number :5280001

Rotterdam, , 3015 CE

Investigational Site Number :7240001, Barcelona, Barcelona [Barcelona], Spain

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Investigational Site Number :7240001

Barcelona, Barcelona [Barcelona], 08035

Investigational Site Number :7240006, Hospitalet de Llobregat, Castilla Y León, Spain

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Investigational Site Number :7240006

Hospitalet de Llobregat, Castilla Y León, 08908

Investigational Site Number :7240003, Madrid / Madrid, Madrid, Comunidad De, Spain

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Investigational Site Number :7240003

Madrid / Madrid, Madrid, Comunidad De, 28040

Investigational Site Number :7240004, Madrid, Madrid, Comunidad De, Spain

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Investigational Site Number :7240004

Madrid, Madrid, Comunidad De, 28050

Investigational Site Number :7240008, Pamplona, Navarra, Spain

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Investigational Site Number :7240008

Pamplona, Navarra, 31008

Investigational Site Number :7240007, Madrid, Spain

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Investigational Site Number :7240007

Madrid, , 28041

Investigational Site Number :1580005, Kaohsiung, Taiwan

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Investigational Site Number :1580005

Kaohsiung, , 807

Investigational Site Number :1580002, Tainan, Taiwan

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Investigational Site Number :1580002

Tainan, , 704

Investigational Site Number :1580001, Taipei 100, Taiwan

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Investigational Site Number :1580001

Taipei 100, ,

Investigational Site Number :1580003, Taipei, Taiwan

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Investigational Site Number :1580003

Taipei, , 104

Investigational Site Number :1580006, Taipei, Taiwan

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Investigational Site Number :1580006

Taipei, , 112

Investigational Site Number :1580004, Taipei, Taiwan

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Investigational Site Number :1580004

Taipei, , 114

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