Trial · NCT03769181
A Study of Isatuximab-based Therapy in Participants With Lymphoma
NCT03769181, Phase 1, Phase 2, Terminated, Sanofi; results first posted 2023-10-17
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study of Isatuximab-based Therapy in Participants With Lymphoma. Trials, record NCT03769181. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03769181
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study of Isatuximab-based Therapy in Participants With Lymphoma
- NCT number
- NCT03769181
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 58 participants, actual
- Lead sponsor
- Sanofi
- Conditions
- Lymphoma
- Interventions
- isatuximab SAR650984, cemiplimab REGN2810
- First posted
- 2018-12-07
- Last updated
- 2025-09-23
- Other registries' IDs
- eudract:2018-002442-37
- Results first posted
- 2023-10-17
- Limitations and caveats
The efficacy results observed in Cohorts B and C did not fulfill the pre-planned interim analysis criteria allowing the study to move to Phase 2 Stage 2 in these cohorts. The efficacy results observed in Cohort A1 and A2 fulfilled the pre-planned interim analysis criteria in Stage 1 to move to Phase 2 Stage 2 in these cohorts. However, the study was stopped for all the cohorts as per Sponsor's decision.
Source ClinicalTrials.gov
Registered outcomes33
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (28 days) | DLTs: Adverse Events (AEs) occurring during 1st treatment cycle, unless due to disease progression or obviously unrelated cause which included: hematological abnormalities: Grade(G) 4 neutropenia(N) for 7 or more consecutive days, G3 to G4 N with fever (temperature greater than or equal to \[\>=\] 38.5 degree Celsius on more than 1 occasion) or microbiologically/radiographically documented infection, G3 to G4 thrombocytopenia with clinically significant bleeding requiring clinical intervention or non-hematological abnormalities: G 4 non-hematologic AE, G\>=2 uveitis, G3 non-hematological AE lasting greater than (\>)3 days, delay in initiation of Cycle 2 \>14 days due to treatment related laboratory abnormalities/AE. Any other AE that the study committee deemed to be dose-limiting, regardless of grade, was also considered as DLT. |
| Primary | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | An AE was defined as any untoward medical occurrence in a participant who received study drug and did not necessarily have to have a causal relationship with the treatment. Serious adverse events (SAEs) were any untoward medical occurrence that at any dose: resulted in death, was life-threatening, required inpatient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, was a congenital anomaly/birth defect, was a medically important event. TEAEs were defined as AEs that developed, worsened or became serious during the TEAE period (defined as the time from the first dose of study treatment up to 30 days after the last dose of study treatment). |
| Primary | Number of Participants With Laboratory Abnormalities: Hematological Parameters | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Hematological parameters assessed were anemia, white blood cell (WBC) decreased, platelet count decreased, lymphocyte count decreased, and neutrophil count decreased. Abnormality criteria was assessed as per the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 NCI-CTCAE v 5.0), where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
| Primary | Number of Participants With Laboratory Abnormalities: Electrolytes | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Electrolyte parameters assessed were hyponatremia, hypokalemia, hyperkalemia, hypocalcemia, hypercalcemia, hypoalbuminemia, hypoglycemia and hyperglycemia. Abnormal criteria was assessed as per the NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
| Primary | Number of Participants With Laboratory Abnormalities: Renal Parameters | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Abnormal renal parameters assessed were glomerular filtration rate (GFR) by class, creatinine increased and hyperuricemia. GFR by class was assessed in categories:\>=90 milliliter per minute per 1.73 meter square (mL/min/1.73m\^2) (Normal), \>=60 to \<90 mL/min/1.73m\^2 (Mild), \>=30 to \<60 mL/min/1.73m\^2 (Moderate), \>=15 to \<30 mL/min/1.73m\^2 (Severe), and \<15 mL/min/1.73m\^2 (End Stage Renal Disease). Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
| Primary | Number of Participants With Laboratory Abnormalities: Liver Function Parameters | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Abnormal liver function parameters assessed were aspartate aminotransferase (AST) increased, alanine aminotransferase (ALT) increased, alkaline phosphatase (ALP) increased, blood bilirubin (BB) increased. Abnormal criteria was assessed as per NCI-CTCAE v 5.0, where Grade 1 = Mild; Grade 2 = Moderate; Grade 3 = Severe; Grade 4 = Potentially Life Threatening. Grade refers to the severity of the AEs. |
| Primary | Cohort A1: Percentage of Participants With Complete Response (CR) | From the date of randomization until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) | Percentage of participants who had a CR as a best overall response (BOR) using the Lugano response criteria (LRC) 2014 (based on PET-CT and CT responses). Per LRC, CR based on PET-CT response was defined as complete metabolic response (MR) in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass, on 5-point scale (5PS), where, 1= no uptake above background; 2 = uptake \<=mediastinum; 3 = uptake \> mediastinum but \<= liver; 4 = uptake moderately \> liver; 5 = uptake markedly higher than liver and/or new lesions; no new lesions and no evidence of fluorodeoxyglucose (FDG)-avid disease in bone marrow. CR based on CT-response was defined as target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to \<=1.5 cm in longest dimension transverse diameter of lesion (LDi); absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology; if indeterminate, immunohistochemistry negative. |
| Primary | Cohort A2, B and C: Percentage of Participants With Objective Response (OR) | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) | Percentage of participants who had a CR or partial response (PR) as BOR using LRC, 2014. Per LRC, CR (PET-CT): complete MR in lymph nodes and extralymphatic sites with a score of 1, 2, or 3 with or without residual mass; no new lesions and no evidence of FDG-avid disease. CR (CT-response): target nodes/nodal masses of lymph nodes, extralymphatic sites regressed to \<=1.5cm LDi; absence of non-measured lesion; organ enlargement regressed to normal; no new lesions; normal bone marrow morphology. PR (PET-CT): partial MR in lymph nodes and extralymphatic sites; no new lesions and residual uptake higher than uptake. PR (Per CT): lymph nodes, extralymphatic sites\>=50% decrease in sum of product of perpendicular diameters (SPD), extranodal sites; if lesion is too small to measure on CT,assign5mm\*5mm as default; if no longer visible:0\*0mm; Node\>5mm\*5mm but smaller than normal, use actual measurement; absent/regressed non-measured lesions; no increase; spleen regressed by\>50% or no new lesions. |
| Secondary | Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Isatuximab | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. |
| Secondary | Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Cemiplimab | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | ADA responses were categorized as treatment boosted ADA and treatment-induced ADA. Treatment boosted ADA was defined as pre-existing ADAs with a significant increase in the ADA titer during the study compared to the Baseline titer. Treatment-induced ADA was defined as ADA that developed at any time during the ADA on-study observation period in participants without pre-existing ADA. |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 registered outcomesOutcomes33
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Dose Limiting Toxicities (DLTs) | Cycle 1 (28 days) | Analysis was performed on DLT evaluable population which included all participants who received the planned doses of isatuximab and cemiplimab during Cycle 1 and completed the DLT observation period after the first administration of the study drug. Here, 0 in the overall number of participants analyzed signifies that no participants were evaluable for DLTs in the Cohort A1 arm. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Analysis was performed on all treated population which included all participants who signed the informed consent and received at least 1 dose of the study treatment, either isatuximab or cemiplimab. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities: Hematological Parameters | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Analysis was performed on all treated population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities: Electrolytes | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Analysis was performed on all treated population. Here number analyzed signifies the participants with available data for each specified parameter. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities: Renal Parameters | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Analysis was performed on all treated population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Laboratory Abnormalities: Liver Function Parameters | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Analysis was performed on all treated population. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Cohort A1: Percentage of Participants With Complete Response (CR) | From the date of randomization until disease progression or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) | Analysis was performed on all treated population. Data for this outcome measure was not planned to be collected and analyzed for Cohort B and C as pre-specified in protocol. | percentage of participants | NUMBER |
| PRIMARY | Cohort A2, B and C: Percentage of Participants With Objective Response (OR) | From the date of randomization until disease progression, or death or study cut-off date, whichever comes first (maximum duration: up to 103 weeks) | Analysis was performed on all treated population. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Isatuximab | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Analysis was performed on Anti-drug antibody (ADA) evaluable population that included all participants who signed informed consent and received at least 1 dose of either isatuximab or cemiplimab, with at least 1 non-missing ADA result after the drug administration. Here, overall number of participants analyzed signifies the participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Number of Participants With Treatment-Induced and Treatment Boosted Antidrug Antibodies (ADA) Against Cemiplimab | From first dose of study treatment up to 30 days after last dose of study treatment (maximum duration: up to 103 weeks) | Analysis was performed on ADA evaluable population. Here, overall number of participants analyzed signifies the participants with available data for this outcome measure. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 33Source ClinicalTrials.gov
See all 33 outcomesResults by group565
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Dose Limiting Toxicities (DLTs) | Cohort A2: cHL: Isatuximab + Cemiplimab | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Cohort B: DLBCL: Isatuximab + Cemiplimab | 0 | Participants | ||
| Number of Participants With Dose Limiting Toxicities (DLTs) | Cohort C: PTCL: Isatuximab + Cemiplimab | 0 | Participants | ||
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A1: cHL: Isatuximab + Cemiplimab | TEAEs | 16 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A2: cHL: Isatuximab + Cemiplimab | TEAEs | 12 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort B: DLBCL: Isatuximab + Cemiplimab | TEAEs | 17 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort C: PTCL: Isatuximab + Cemiplimab | TEAEs | 11 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A1: cHL: Isatuximab + Cemiplimab | TESAEs | 3 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort A2: cHL: Isatuximab + Cemiplimab | TESAEs | 2 | Participants | |
| Number of Participants With Treatment-Emergent Adverse Events (TEAEs), and Treatment-Emergent Serious Adverse Events (TESAEs) | Cohort B: DLBCL: Isatuximab + Cemiplimab | TESAEs | 10 | Participants |
1 to 10 of 565Source ClinicalTrials.gov
See all 565 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort A1: cHL: Isatuximab + Cemiplimab | 18 | |
| Overall Study | STARTED | Cohort A2: cHL: Isatuximab + Cemiplimab | 12 | |
| Overall Study | STARTED | Cohort B: DLBCL: Isatuximab + Cemiplimab | 17 | |
| Overall Study | STARTED | Cohort C: PTCL: Isatuximab + Cemiplimab | 11 | |
| Overall Study | COMPLETED | Cohort A1: cHL: Isatuximab + Cemiplimab | 5 | |
| Overall Study | COMPLETED | Cohort A2: cHL: Isatuximab + Cemiplimab | 4 | |
| Overall Study | COMPLETED | Cohort B: DLBCL: Isatuximab + Cemiplimab | 0 | |
| Overall Study | COMPLETED | Cohort C: PTCL: Isatuximab + Cemiplimab | 0 | |
| Overall Study | NOT COMPLETED | Cohort A1: cHL: Isatuximab + Cemiplimab | 13 | |
| Overall Study | NOT COMPLETED | Cohort A2: cHL: Isatuximab + Cemiplimab | 8 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events720
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Bacteraemia | Infections and infestations | Cohort A1: cHL: Isatuximab + Cemiplimab | 0 | 18 | 0 |
| other | Bacteraemia | Infections and infestations | Cohort A2: cHL: Isatuximab + Cemiplimab | 0 | 12 | 0 |
| other | Bacteraemia | Infections and infestations | Cohort B: DLBCL: Isatuximab + Cemiplimab | 1 | 17 | 1 |
| other | Bacteraemia | Infections and infestations | Cohort C: PTCL: Isatuximab + Cemiplimab | 0 | 11 | 0 |
| other | Bacterial Diarrhoea | Infections and infestations | Cohort A1: cHL: Isatuximab + Cemiplimab | 1 | 18 | 1 |
| other | Bacterial Diarrhoea | Infections and infestations | Cohort A2: cHL: Isatuximab + Cemiplimab | 0 | 12 | 0 |
| other | Bacterial Diarrhoea | Infections and infestations | Cohort B: DLBCL: Isatuximab + Cemiplimab | 0 | 17 | 0 |
| other | Bacterial Diarrhoea | Infections and infestations | Cohort C: PTCL: Isatuximab + Cemiplimab | 0 | 11 | 0 |
| other | Bronchitis | Infections and infestations | Cohort A1: cHL: Isatuximab + Cemiplimab | 1 | 18 | 1 |
| other | Bronchitis | Infections and infestations | Cohort A2: cHL: Isatuximab + Cemiplimab | 1 | 12 | 1 |
1 to 10 of 720Source ClinicalTrials.gov
See all 720 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort A1: cHL: Isatuximab + Cemiplimab | 4 | 18 |
| Total, all-cause mortality | Cohort A2: cHL: Isatuximab + Cemiplimab | 0 | 12 |
| Total, all-cause mortality | Cohort B: DLBCL: Isatuximab + Cemiplimab | 12 | 17 |
| Total, all-cause mortality | Cohort C: PTCL: Isatuximab + Cemiplimab | 6 | 11 |
| Total, other adverse events | Cohort A1: cHL: Isatuximab + Cemiplimab | 16 | 18 |
| Total, other adverse events | Cohort A2: cHL: Isatuximab + Cemiplimab | 12 | 12 |
| Total, other adverse events | Cohort B: DLBCL: Isatuximab + Cemiplimab | 17 | 17 |
| Total, other adverse events | Cohort C: PTCL: Isatuximab + Cemiplimab | 10 | 11 |
| Total, serious adverse events | Cohort A1: cHL: Isatuximab + Cemiplimab | 3 | 18 |
| Total, serious adverse events | Cohort A2: cHL: Isatuximab + Cemiplimab | 2 | 12 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 36251503 | BACKGROUND |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03769181
GET https://conductscience.org/api/trials/v1/NCT03769181/registered?page=2