TriangleNCT03905135 · STUDY IN CONTEXT
Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
Draft scope assessment: unclear. Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
Read the full study record and all posted results →
Linked outcomes
The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity, if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to interleukin-15 (IL-5) by the principal investigator (PI) or designee during the first 28 days of treatment. Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first, and was estimated using Kaplan-Meier curves along with a 95% confidence interval. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
OS is defined as the time from the date of study enrollment until time of death from any cause and was estimated using Kaplan-Meier curves along with a 95% confidence interval.
Response was assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria and reported along with a 95% confidence interval. Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion.
OR is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
Reported safety
Quality of life and patient-reported measures
No linked quality-of-life measure is recorded for this setting and study.
Full draft applicability and source-link record
- trial
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- trial label
- Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
- applicability
- unclear
- applicability note
- Attached because the study's own record describes recurrent disease. The study was not selected for this indication by its sponsor, and its eligibility has not been reconciled against this page in full.
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- provenance class
- registry-condition-search
- discovery note
- Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
- outcome Count
- 6
- harms Count
- 2
- qol Count
- 0
- outcomes
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0000
- source section id
- NCT03905135-om-0000
- source outcome index
- 0
- endpoint
- Maximum Tolerated Dose (MTD) of Interleukin 15
- endpoint definition
- The MTD is the dose level at which no more than 1 of up to 6 participants experience a dose-limiting toxicity (DLT) during the DLT evaluation window(s), or the dose below that at which at least 2 (of ≤6) participants have DLT. A dose-limiting toxicity (DLT) is defined as: any grade 3, 4, or 5 toxicity, if not incontrovertibly due to disease progression or an extraneous cause, and deemed possibly, probably or definitely related to interleukin-15 (IL-5) by the principal investigator (PI) or designee during the first 28 days of treatment. Grade 3 is severe. Grade 4 is life threatening. Grade 5 is death related to adverse event.
- time origin
- First 28 days of treatment
- analysis role
- primary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0001
- source section id
- NCT03905135-om-0001
- source outcome index
- 1
- endpoint
- Mean Progression Free Survival (PFS)
- endpoint definition
- PFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, or death, whichever occurs first. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
- time origin
- From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0002
- source section id
- NCT03905135-om-0002
- source outcome index
- 2
- endpoint
- Mean Event-free Survival (EFS)
- endpoint definition
- EFS is defined as the duration of time from the date of study enrollment until time of disease relapse, disease progression, alternative therapy for lymphoma given (such as radiation), or death, whichever occurs first, and was estimated using Kaplan-Meier curves along with a 95% confidence interval. Disease relapse is Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
- time origin
- From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0003
- source section id
- NCT03905135-om-0003
- source outcome index
- 3
- endpoint
- Mean Overall Survival (OS)
- endpoint definition
- OS is defined as the time from the date of study enrollment until time of death from any cause and was estimated using Kaplan-Meier curves along with a 95% confidence interval.
- time origin
- From study opening through May 2022 when the study was completed with a maximum follow up of approximately 2 years and 11 months for any participant.
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0004
- source section id
- NCT03905135-om-0004
- source outcome index
- 4
- endpoint
- Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells
- endpoint definition
- Response was assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria and reported along with a 95% confidence interval. Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion.
- time origin
- From the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0005
- source section id
- NCT03905135-om-0005
- source outcome index
- 5
- endpoint
- Number of Participants With Overall Best Response
- endpoint definition
- OR is the best response recorded from the start of the treatment until disease progression/recurrence (taking as reference for progressive disease the smallest measurements recorded since the treatment started). Complete response is complete disappearance of all target lesions. Partial response is ≥30% decrease in the sum of longest diameters of target lesions but not a complete response. Minor response is ≥10% decrease in the sum of longest diameters of target lesions but not a partial response. Stable disease is \<10% decrease or ≤20% increase in the sum of longest diameters of target lesions. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion assessed by the Response Evaluation Criteria in Lymphoma (RECIL) 2017 criteria.
- time origin
- 6 cycles (each cycle is 28 days) - approximately 168 days
- analysis role
- secondary
- reporting status
- POSTED
- data cutoff
- Source null
- population note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- arms
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0000
- arm key
- OG000
- arm label
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0000#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0000
- arm key
- OG001
- arm label
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0000#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0001
- arm key
- OG000
- arm label
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0001#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0001
- arm key
- OG001
- arm label
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0001#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0002
- arm key
- OG000
- arm label
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0002#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0002
- arm key
- OG001
- arm label
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0002#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0003
- arm key
- OG000
- arm label
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0003#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0003
- arm key
- OG001
- arm label
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0003#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0004
- arm key
- OG000
- arm label
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0004#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0004
- arm key
- OG001
- arm label
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0004#groups/OG001
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0005
- arm key
- OG000
- arm label
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a starting dose level of 1 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 6
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0005#groups/OG000
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- outcome key
- om-0005
- arm key
- OG001
- arm label
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- regimen
- Interleukin-15 (IL-15) will be administered by continuous intravenous infusion in a dose-escalation fashion with a second dose level of 2 mcg/kg/day on days 1-5 of each of six cycles. Avelumab (intravenous (IV) over 1 hour) will be administered at a dose of 10 mg/kg on days 8 and 22 of each of six cycles.
- analyzed count
- 2
- analyzed unit
- Participants
- is comparator
- Source null
- source pointer
- NCT03905135-om-0005#groups/OG001
- harms
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- harm key
- EG000
- source section id
- NCT03905135-ae
- event group key
- EG000
- event group label
- Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab
- serious affected
- 6
- serious at risk
- 6
- other affected
- 3
- other at risk
- 6
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2.
- event definition
- Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- release id
- clinical-indications-draft-1
- disease state id
- ds-mycosis-fungoides-adcetris-830bfb95
- nct id
- NCT03905135
- harm key
- EG001
- source section id
- NCT03905135-ae
- event group key
- EG001
- event group label
- Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab
- serious affected
- 0
- serious at risk
- 2
- other affected
- 2
- other at risk
- 2
- frequency threshold
- 0
- collection period
- Date treatment consent signed to date off study, approximately 21 months and 18 days for the dose level 1 and 3 months and 19 days for the dose level 2.
- event definition
- Three participants died from disease progression during the long-term survival follow-up phase of the study (they were only being called once every 3 months to check to see if they died and to learn of new cancer treatments). We were no longer tracking adverse events (AEs) at the time of death, thus only one death from progressive disease is listed in the serious adverse events table below.
- undenominated note
- Source null
- curation status
- draft
- reviewed by
- Source null
- reviewed at
- Source null
- created at
- 2026-09-10T00:00:00Z
- quality of life
- setting source links
Preserved source evidence · Not medical advice