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History of Changes for Study: NCT03871348
A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Latest version (submitted August 11, 2022) on ClinicalTrials.gov
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Study Record Versions
Version A B Submitted Date Changes
1 March 10, 2019 None (earliest Version on record)
2 November 19, 2019 Outcome Measures, Eligibility and Study Status
3 January 24, 2020 Study Status and Contacts/Locations
4 February 5, 2020 Study Status
5 May 12, 2020 Study Status
6 June 26, 2020 Study Status
7 July 20, 2020 Study Status and Contacts/Locations
8 July 31, 2020 Contacts/Locations and Study Status
9 August 20, 2020 Study Status
10 August 25, 2020 Contacts/Locations and Study Status
11 August 26, 2020 Outcome Measures, Arms and Interventions, Eligibility, Study Design, Study Description and Study Status
12 September 11, 2020 Study Status
13 November 24, 2020 Study Status and Contacts/Locations
14 December 15, 2020 Study Status
15 July 23, 2021 Study Status and Study Description
16 October 12, 2021 Contacts/Locations and Study Status
17 December 3, 2021 Study Status and Contacts/Locations
18 January 13, 2022 Study Status and Contacts/Locations
19 April 5, 2022 Study Status
20 April 25, 2022 Study Status and Contacts/Locations
21 April 27, 2022 Study Status and Contacts/Locations
22 May 4, 2022 Study Status and IPDSharing
23 June 28, 2022 Recruitment Status, Study Status and Contacts/Locations
24 August 11, 2022 Study Status and Study Design
Comparison Format:

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Changes (Side-by-Side) for Study: NCT03871348
June 28, 2022 (v23) -- August 11, 2022 (v24)

Changes in: Study Status and Study Design

Open or close this module Study Identification
Unique Protocol ID: TED15297 TED15297
Brief Title: A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors A First-in-Human Dose Escalation and Expansion Study to Evaluate Intratumoral Administration of SAR441000 as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Official Title: A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors A Phase 1 First-in-Human Dose Escalation and Expansion Study for the Evaluation of Safety, Pharmacokinetics, Pharmacodynamics and Anti-tumor Activity of SAR441000 Administered Intratumorally as Monotherapy and in Combination With Cemiplimab in Patients With Advanced Solid Tumors
Secondary IDs: 2017-004766-94 [EudraCT Number]
U1111-1205-1176 [UTN]
2017-004766-94 [EudraCT Number]
U1111-1205-1176 [UTN]
Open or close this module Study Status
Record Verification: June 28, 2022 August 2022
Overall Status: Active, not recruitingActive, not recruiting
Study Start: January 3, 2019 January 3, 2019
Primary Completion: August 3, 2022 [Anticipated] July 25, 2022 [Actual]
Study Completion: March 29, 2024 [Anticipated] March 29, 2024 [Anticipated]
First Submitted: January 24, 2019 January 24, 2019
First Submitted that
Met QC Criteria:
March 10, 2019 March 10, 2019
First Posted: March 12, 2019 [Actual] March 12, 2019 [Actual]
Last Update Submitted that
Met QC Criteria:
June 28, 2022 August 11, 2022
Last Update Posted: June 30, 2022 [Actual] August 12, 2022 [Actual]
Open or close this module Sponsor/Collaborators
Sponsor: Sanofi Sanofi
Responsible Party: Sponsor Sponsor
Collaborators: BioNTech RNA Pharmaceuticals GmbH BioNTech RNA Pharmaceuticals GmbH
Open or close this module Oversight
U.S. FDA-regulated Drug: YesYes
U.S. FDA-regulated Device: NoNo
Data Monitoring: No No
Open or close this module Study Description
Brief Summary:

Primary Objectives:

  • Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options.
  • Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.

Secondary Objectives:

  • To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab.
  • To assess the immunogenicity of SAR441000.
  • To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab.
  • To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000.
  • To determine the recommended dose of SAR441000 for the expansion phase.

Primary Objectives:

  • Dose Escalation: To determine maximum tolerated dose (MTD) or maximum administered dose (MAD) and overall safety and tolerability profile of SAR441000 when administered intratumorally as monotherapy and in combination with cemiplimab in patients who have no alternative standard treatment options.
  • Dose Expansion (Combination): To determine the objective response rate of SAR441000 administered intratumorally in combination with cemiplimab in patients with melanoma, cutaneous squamous cell carcinoma or head and neck squamous cell carcinoma.

Secondary Objectives:

  • To characterize the pharmacokinetic (PK) profile of SAR441000 administered as monotherapy and in combination with cemiplimab.
  • To assess the immunogenicity of SAR441000.
  • To characterize the safety of SAR441000 when administered intratumorally in combination with cemiplimab.
  • To determine the disease control rate (DCR), duration of response (DoR) and progression free survival (PFS) of SAR441000.
  • To determine the recommended dose of SAR441000 for the expansion phase.
Detailed Description:

The expected duration of treatment for patients who benefit from study intervention may vary, based on progression date. Median expected duration of study per patient is estimated as 9 months in monotherapy and 12 months in combination therapy.

The maximum treatment duration for non-progressive patients is up to 2 years.

The expected duration of treatment for patients who benefit from study intervention may vary, based on progression date. Median expected duration of study per patient is estimated as 9 months in monotherapy and 12 months in combination therapy.

The maximum treatment duration for non-progressive patients is up to 2 years.

Open or close this module Conditions
Conditions: Metastatic Neoplasm Metastatic Neoplasm
Keywords:
Open or close this module Study Design
Study Type: InterventionalInterventional
Primary Purpose: TreatmentTreatment
Study Phase: Phase 1Phase 1
Interventional Study Model: Parallel Assignment Parallel Assignment
Number of Arms: 66
Masking: None (Open Label)None (Open Label)
Allocation: Non-RandomizedNon-Randomized
Enrollment: 231 [Anticipated] 77 [Actual]
Open or close this module Arms and Interventions
Arms Assigned Interventions
Experimental: SAR441000 Dose Escalation Phase
SAR441000 will be administered as intratumoral injection as monotherapy in patients with solid tumors over a 28-day cycle
Drug: SAR441000

Pharmaceutical form: concentrate for solution for injection

Route of administration: intratumoral

Experimental: SAR441000 + cemiplimab - Dose Escalation Phase
SAR441000 will be administered as intratumoral injection in patients with solid tumors in combination with cemiplimab over a 21-day cycle
Drug: SAR441000

Pharmaceutical form: concentrate for solution for injection

Route of administration: intratumoral

Drug: Cemiplimab REGN2810

Pharmaceutical form: solution for injection

Route of administration: intravenous

Experimental: SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 failure
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced melanoma who have failed anti-PD-1/PD-L1 therapy. Treatment is administered over a 21-day cycle
Drug: SAR441000

Pharmaceutical form: concentrate for solution for injection

Route of administration: intratumoral

Drug: Cemiplimab REGN2810

Pharmaceutical form: solution for injection

Route of administration: intravenous

Experimental: SAR441000 + cemiplimab Expansion Melanoma, anti-PD-1 naive
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve melanoma over a 21-day cycle
Drug: SAR441000

Pharmaceutical form: concentrate for solution for injection

Route of administration: intratumoral

Drug: Cemiplimab REGN2810

Pharmaceutical form: solution for injection

Route of administration: intravenous

Experimental: SAR441000 + cemiplimab Expansion CSCC, anti-PD-1 naive
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Cutaneous Squamous Cell Carcinoma (CSCC) over a 21-day cycle
Drug: SAR441000

Pharmaceutical form: concentrate for solution for injection

Route of administration: intratumoral

Drug: Cemiplimab REGN2810

Pharmaceutical form: solution for injection

Route of administration: intravenous

Experimental: SAR441000 + cemiplimab Expansion HNSCC, anti-PD-1 naive
SAR441000 will be administered intratumorally at the determined recommended dose in combination with cemiplimab to patients with advanced anti-PD-1/PD-L1 naïve Head and Neck Squamous Cell Cancer (HNSCC) over a 21-day cycle
Drug: SAR441000

Pharmaceutical form: concentrate for solution for injection

Route of administration: intratumoral

Drug: Cemiplimab REGN2810

Pharmaceutical form: solution for injection

Route of administration: intravenous

Open or close this module Outcome Measures
Primary Outcome Measures:
1. For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Monotherapy)
[ Time Frame: Cycle 1; Cycle = 28 days for monotherapy ]

Incidence of DLTs at Cycle 1 (SAR441000 monotherapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression
For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Monotherapy)
[ Time Frame: Cycle 1; Cycle = 28 days for monotherapy ]

Incidence of DLTs at Cycle 1 (SAR441000 monotherapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression
2. For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Combination therapy)
[ Time Frame: Cycle 1 Day 1 to Cycle 2 Day 8; Cycle = 21 days for combination therapy; overall assessment = 28 days ]

Incidence of DLTs during period from Cycle 1 Day 1 to Cycle 2 Day 8 (SAR441000 + cemiplimab combination therapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using NCI-CTCAE version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression
For dose escalation: Incidence of Dose Limiting Toxicities (DLTs) (Combination therapy)
[ Time Frame: Cycle 1 Day 1 to Cycle 2 Day 8; Cycle = 21 days for combination therapy; overall assessment = 28 days ]

Incidence of DLTs during period from Cycle 1 Day 1 to Cycle 2 Day 8 (SAR441000 + cemiplimab combination therapy), assessed as the occurrence of AE, satisfying protocol defined DLT criteria, using NCI-CTCAE version 5.0 whether related or not to the study treatment in the absence of clear evidence to the contrary, and if not related to a disease progression
3. For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Monotherapy)
[ Time Frame: End of Dose Escalation phase (ie, End of Cycle 1 for last patient); Cycle = 28 days for monotherapy ]

MTD of SAR441000 as monotherapy, determined during Cycle 1 of dose escalation phase
For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Monotherapy)
[ Time Frame: End of Dose Escalation phase (ie, End of Cycle 1 for last patient); Cycle = 28 days for monotherapy ]

MTD of SAR441000 as monotherapy, determined during Cycle 1 of dose escalation phase
4. For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Combination therapy)
[ Time Frame: End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days ]

MTD of SAR441000, in combination with cemiplimab, determined during period from Cycle 1 Day 1 to Cycle 2 Day 8 in dose escalation phase
For dose escalation: Maximum tolerated dose (MTD) of SAR441000 (Combination therapy)
[ Time Frame: End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days ]

MTD of SAR441000, in combination with cemiplimab, determined during period from Cycle 1 Day 1 to Cycle 2 Day 8 in dose escalation phase
5. Adverse Events
[ Time Frame: Up to end of treatment (Estimated median duration=12 months) ]

Incidence of Treatment Emergent Adverse Events (TEAE) during dose escalation phase
Adverse Events
[ Time Frame: Up to end of treatment (Estimated median duration=12 months) ]

Incidence of Treatment Emergent Adverse Events (TEAE) during dose escalation phase
6. For Expansion: Objective Response Rate (ORR)
[ Time Frame: Estimated median duration = 12 months ]

Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
For Expansion: Objective Response Rate (ORR)
[ Time Frame: Estimated median duration = 12 months ]

Assessment of overall response rate using standard imaging and RECIST 1.1 criteria
Secondary Outcome Measures:
1. Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Monotherapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy ]

Maximum plasma concentration (Cmax) of SAR4410000 as monotherapy observed over the dosing interval
Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Monotherapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy ]

Maximum plasma concentration (Cmax) of SAR4410000 as monotherapy observed over the dosing interval
2. Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Combination therapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy ]

Maximum plasma concentration (Cmax) of SAR4410000 in combination with cemiplimab observed over the dosing interval
Assessment of Pharmacokinetic (PK) parameter for SAR441000 (Cmax) (Combination therapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy ]

Maximum plasma concentration (Cmax) of SAR4410000 in combination with cemiplimab observed over the dosing interval
3. Assessment of PK parameter for SAR441000 (AUC) (Monotherapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy ]

Area under the plasma concentration versus time curve (AUC) of SAR441000 as monotherapy over the dosing interval
Assessment of PK parameter for SAR441000 (AUC) (Monotherapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 28 days for monotherapy ]

Area under the plasma concentration versus time curve (AUC) of SAR441000 as monotherapy over the dosing interval
4. Assessment of PK parameter for SAR441000 (AUC) (Combination therapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy ]

Area under the plasma concentration versus time curve (AUC) of SAR441000 in combination with cemiplimab over the dosing interval
Assessment of PK parameter for SAR441000 (AUC) (Combination therapy)
[ Time Frame: Cycle 1 Week 1 and Cycle 3 Week 1 (in all patients); Cycle duration is 21 days for combination therapy ]

Area under the plasma concentration versus time curve (AUC) of SAR441000 in combination with cemiplimab over the dosing interval
5. Assessment of PK parameter (Ctrough) for SAR441000
[ Time Frame: Baseline to End of Treatment (Estimated median duration of 12 months) ]

Trough Plasma Concentration (Ctrough) of SAR441000 as monotherapy and in combination with cemiplimab. It is defined as plasma concentration observed just before treatment administration during repeated dosing
Assessment of PK parameter (Ctrough) for SAR441000
[ Time Frame: Baseline to End of Treatment (Estimated median duration of 12 months) ]

Trough Plasma Concentration (Ctrough) of SAR441000 as monotherapy and in combination with cemiplimab. It is defined as plasma concentration observed just before treatment administration during repeated dosing
6. Assessment of PK parameter for cemiplimab (Cmax)
[ Time Frame: Cycle 1; Cycle duration is 21 days ]

Maximum plasma concentration of cemiplimab in combination with SAR441000, observed over the dosing interval
Assessment of PK parameter for cemiplimab (Cmax)
[ Time Frame: Cycle 1; Cycle duration is 21 days ]

Maximum plasma concentration of cemiplimab in combination with SAR441000, observed over the dosing interval
7. Assessment of PK parameter of cemiplimab (AUC)
[ Time Frame: Cycle 1; Cycle duration is 21 days ]

Area under the plasma concentration versus time curve of cemiplimab in combination with SAR441000 over the dosing interval
Assessment of PK parameter of cemiplimab (AUC)
[ Time Frame: Cycle 1; Cycle duration is 21 days ]

Area under the plasma concentration versus time curve of cemiplimab in combination with SAR441000 over the dosing interval
8. Assessment of PK parameter for cemiplimab (Ctrough)
[ Time Frame: Baseline to End of Treatment (Estimated median duration of 12 months) ]

Trough plasma concentration of cemiplimab in combination with SAR441000, observed just before treatment administration during repeated dosing
Assessment of PK parameter for cemiplimab (Ctrough)
[ Time Frame: Baseline to End of Treatment (Estimated median duration of 12 months) ]

Trough plasma concentration of cemiplimab in combination with SAR441000, observed just before treatment administration during repeated dosing
9. Immunogenicity of SAR441000 and cemiplimab
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Incidence of anti-drug antibody (ADA) positive patients for immunogenicity
Immunogenicity of SAR441000 and cemiplimab
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Incidence of anti-drug antibody (ADA) positive patients for immunogenicity
10. DCR
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Disease Control Rate (DCR) with SAR441000 in combination with cemiplimab. DCR is sum of Complete Response + Partial Response + Stable Disease
DCR
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Disease Control Rate (DCR) with SAR441000 in combination with cemiplimab. DCR is sum of Complete Response + Partial Response + Stable Disease
11. DoR
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Duration of Response (DoR) with SAR441000 in combination with cemiplimab. DoR is time from initial response to the first documented tumor progression
DoR
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Duration of Response (DoR) with SAR441000 in combination with cemiplimab. DoR is time from initial response to the first documented tumor progression
12. Progression Free Survival (PFS)
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Time from first drug administration to the first documented tumor progression or death from any cause, whichever comes first
Progression Free Survival (PFS)
[ Time Frame: Baseline to End of Study (Estimated median duration of 12 months) ]

Time from first drug administration to the first documented tumor progression or death from any cause, whichever comes first
13. Incidence of Treatment Emergent Adverse Events (TEAE) during dose expansion phase
[ Time Frame: Baseline to End of Treatment (Estimated median duration of 12 months) ]

Incidence of Adverse Events (AE)/ Serious AE (SAE) / Laboratory abnormalities considered to be adverse events
Incidence of Treatment Emergent Adverse Events (TEAE) during dose expansion phase
[ Time Frame: Baseline to End of Treatment (Estimated median duration of 12 months) ]

Incidence of Adverse Events (AE)/ Serious AE (SAE) / Laboratory abnormalities considered to be adverse events
14. Recommended dose of SAR441000 for expansion phase (Combination therapy)
[ Time Frame: End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days ]

SAR441000 dose for administration in combination with cemiplimab selected for expansion phase based on MTD/MAD by the Bayesian model, the overall safety, activity and PK/PDy data
Recommended dose of SAR441000 for expansion phase (Combination therapy)
[ Time Frame: End of Dose Escalation Phase (ie, End of Cycle 1 Day 1 to Cycle 2 Day 8 for last patient); Cycle = 21 days for combination; overall assesment = 28 days ]

SAR441000 dose for administration in combination with cemiplimab selected for expansion phase based on MTD/MAD by the Bayesian model, the overall safety, activity and PK/PDy data
15. For Dose Expansion: Objective Response Rate (ORR)
[ Time Frame: Estimated median duration of 12 months ]

Assessment of overall response rate using standard imaging by RECIST 1.1 and iRECIST criteria
For Dose Expansion: Objective Response Rate (ORR)
[ Time Frame: Estimated median duration of 12 months ]

Assessment of overall response rate using standard imaging by RECIST 1.1 and iRECIST criteria
Open or close this module Eligibility
Minimum Age: 18 Years 18 Years
Maximum Age:
Sex: All All
Gender Based:
Accepts Healthy Volunteers: NoNo
Criteria:

Inclusion criteria:

  • At least 18 years of age
  • Advanced solid tumors including lymphomas for which no standard alternative therapy is available (escalation phase).
  • Advanced melanoma (Stage IIIB-C or Stage IV, anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous Squamous Cell Cancer where no other alternative treatment option exists (expansion phases).
  • Minimum 3 lesions enrollment.
  • Injectable disease (i.e., suitable for direct intratumoral injection based on the dose level volume of each cohort and cumulative lesion size; according to the investigator's judgement).
  • A lesion amenable for additional tumor biopsy.
  • Patients with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
  • Life expectancy more than 3 months.
  • Willingness to provide mandatory tumor biopsy.
  • Male and female patients who agree to use effective contraceptive methods.
  • Signed informed consent.

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance score >1.
  • Significant and uncontrolled concomitant illness that would adversely affect the patient's participation in the study.
  • Any prior organ transplantation.
  • History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected basal or squamous-cell skin cancer or carcinoma, in situ of cervix or other local tumors considered cured by local treatment.
  • History of unresolved viral hepatitis; systemic immune suppression including acquired immunodeficiency syndrome (AIDS) related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
  • Prior splenectomy.
  • New and progressive brain lesions.
  • Poor bone marrow reserve resulting in low blood cell count.
  • Poor liver and kidney functions, abnormal coagulation tests.
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
  • Maintenance therapy with prednisolone >7.5 mg/day orally or equivalent during the study.
  • Non-resolution of any prior treatment related toxicity to Grade <2, except alopecia, vitiligo, fatigue and hypothyroidism controlled with replacement therapies.
  • Moderate to severe immune related adverse event to prior immune-modulating agents within 90 days prior to the first study treatment.
  • Central nervous system lymphoma.
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT) for patients with lymphoma.
  • Autologous HSCT less than 90 days prior to initiation of study intervention.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Inclusion criteria:

  • At least 18 years of age
  • Advanced solid tumors including lymphomas for which no standard alternative therapy is available (escalation phase).
  • Advanced melanoma (Stage IIIB-C or Stage IV, anti-PD-1/PD-L1 treated or not) or anti-PD-1/PD-L1 not treated advanced Head and Neck Squamous Cell Cancer or anti-PD-1/PD-L1 not treated Advanced Cutaneous Squamous Cell Cancer where no other alternative treatment option exists (expansion phases).
  • Minimum 3 lesions enrollment.
  • Injectable disease (i.e., suitable for direct intratumoral injection based on the dose level volume of each cohort and cumulative lesion size; according to the investigator's judgement).
  • A lesion amenable for additional tumor biopsy.
  • Patients with measurable disease according to the Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 criteria.
  • Life expectancy more than 3 months.
  • Willingness to provide mandatory tumor biopsy.
  • Male and female patients who agree to use effective contraceptive methods.
  • Signed informed consent.

Exclusion criteria:

  • Eastern Cooperative Oncology Group (ECOG) performance score >1.
  • Significant and uncontrolled concomitant illness that would adversely affect the patient's participation in the study.
  • Any prior organ transplantation.
  • History within the last 5 years of an invasive malignancy other than the one treated in this study, with the exception of resected basal or squamous-cell skin cancer or carcinoma, in situ of cervix or other local tumors considered cured by local treatment.
  • History of unresolved viral hepatitis; systemic immune suppression including acquired immunodeficiency syndrome (AIDS) related illnesses or human immunodeficiency virus (HIV) disease requiring antiretroviral treatment.
  • Prior splenectomy.
  • New and progressive brain lesions.
  • Poor bone marrow reserve resulting in low blood cell count.
  • Poor liver and kidney functions, abnormal coagulation tests.
  • Ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments.
  • Maintenance therapy with prednisolone >7.5 mg/day orally or equivalent during the study.
  • Non-resolution of any prior treatment related toxicity to Grade <2, except alopecia, vitiligo, fatigue and hypothyroidism controlled with replacement therapies.
  • Moderate to severe immune related adverse event to prior immune-modulating agents within 90 days prior to the first study treatment.
  • Central nervous system lymphoma.
  • Prior allogeneic hematopoietic stem cell transplantation (HSCT) for patients with lymphoma.
  • Autologous HSCT less than 90 days prior to initiation of study intervention.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Open or close this module Contacts/Locations
Study Officials: Clinical Sciences & Operations
Study Director
Sanofi
Clinical Sciences & Operations
Study Director
Sanofi
Locations: United States, KansasUnited States, Kansas
Investigational Site Number :8400001
Fairway, Kansas, United States, 66205
Investigational Site Number :8400001
Fairway, Kansas, United States, 66205
United States, MassachusettsUnited States, Massachusetts
Investigational Site Number :8400003
Boston, Massachusetts, United States, 02115
Investigational Site Number :8400003
Boston, Massachusetts, United States, 02115
United States, OhioUnited States, Ohio
Investigational Site Number :8400007
Cleveland, Ohio, United States, 44195
Investigational Site Number :8400007
Cleveland, Ohio, United States, 44195
United States, TexasUnited States, Texas
Investigational Site Number :8400002
Houston, Texas, United States, 77030
Investigational Site Number :8400002
Houston, Texas, United States, 77030
BelgiumBelgium
Investigational Site Number :0560001
Bruxelles, Belgium, 1200
Investigational Site Number :0560001
Bruxelles, Belgium, 1200
Investigational Site Number :0560003
Gent, Belgium, 9000
Investigational Site Number :0560003
Gent, Belgium, 9000
Investigational Site Number :0560002
Leuven, Belgium, 3000
Investigational Site Number :0560002
Leuven, Belgium, 3000
FranceFrance
Investigational Site Number :2500004
Marseille, France, 13385
Investigational Site Number :2500004
Marseille, France, 13385
Investigational Site Number :2500002
Paris, France, 75010
Investigational Site Number :2500002
Paris, France, 75010
Investigational Site Number :2500001
Villejuif, France, 94800
Investigational Site Number :2500001
Villejuif, France, 94800
GermanyGermany
Investigational Site Number :2760005
Hamburg, Germany, 20246
Investigational Site Number :2760005
Hamburg, Germany, 20246
Investigational Site Number :2760004
Heidelberg, Germany, 69120
Investigational Site Number :2760004
Heidelberg, Germany, 69120
Investigational Site Number :2760001
Mainz, Germany, 55131
Investigational Site Number :2760001
Mainz, Germany, 55131
Investigational Site Number :2760003
Mannheim, Germany, 68167
Investigational Site Number :2760003
Mannheim, Germany, 68167
Investigational Site Number :2760006
Tübingen, Germany, 72076
Investigational Site Number :2760006
Tübingen, Germany, 72076
NetherlandsNetherlands
Investigational Site Number :5280002
Nijmegen, Netherlands, 6525GA
Investigational Site Number :5280002
Nijmegen, Netherlands, 6525GA
Investigational Site Number :5280001
Rotterdam, Netherlands, 3015 GD
Investigational Site Number :5280001
Rotterdam, Netherlands, 3015 GD
SpainSpain
Investigational Site Number :7240002
Valencia, Spain, 46014
Investigational Site Number :7240002
Valencia, Spain, 46014
Spain, Barcelona [Barcelona]Spain, Barcelona [Barcelona]
Investigational Site Number :7240004
Barcelona, Barcelona [Barcelona], Spain, 08036
Investigational Site Number :7240004
Barcelona, Barcelona [Barcelona], Spain, 08036
Spain, NavarraSpain, Navarra
Investigational Site Number :7240001
Pamplona, Navarra, Spain, 31008
Investigational Site Number :7240001
Pamplona, Navarra, Spain, 31008
Investigational Site Number :7240005
Pamplona, Navarra, Spain, 31008
Investigational Site Number :7240005
Pamplona, Navarra, Spain, 31008
Open or close this module IPDSharing
Plan to Share IPD: Yes
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Yes
Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Supporting Information:
Supporting Information:
Time Frame:
Time Frame:
Access Criteria:
Access Criteria:
URL: URL:
Open or close this module References
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Links:
Available IPD/Information:

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