Trial · NCT03905135
Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
NCT03905135, Phase 1, Completed, National Cancer Institute (NCI); results first posted 2022-09-13
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies. Trials, record NCT03905135. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03905135
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Interleukin-15 (IL-5) in Combination With Avelumab (Bavencio) in Relapsed/Refractory Mature T-cell Malignancies
- NCT number
- NCT03905135
- Status
- Completed
- Phases
- Phase 1
- Enrollment
- 8 participants, actual
- Lead sponsor
- National Cancer Institute (NCI)
- Conditions
- Peripheral T-cell Lymphoma NOS, Mycosis Fungoides, Sezary Syndrome, Anaplastic Large Cell Lymphoma
- Interventions
- rhIL-15, rhIL-15, Avelumab
- First posted
- 2019-04-05
- Last updated
- 2022-09-13
- Results first posted
- 2022-09-13
Source ClinicalTrials.gov
Registered outcomes9
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Maximum Tolerated Dose (MTD) of Interleukin 15 | First 28 days of treatment | 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. |
| Secondary | Mean Progression Free Survival (PFS) | 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. | 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. |
| Secondary | Mean Event-free Survival (EFS) | 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. | 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. |
| Secondary | Mean Overall Survival (OS) | 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. | 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. |
| Secondary | Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells | From the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years | 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. |
| Secondary | Number of Participants With Overall Best Response | 6 cycles (each cycle is 28 days) - approximately 168 days | 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. |
| Secondary | Mean Duration of Response (DOR) | From the time that response to therapy is first documented until progressive disease is observed or the subject is lost to follow-up or approximately 2 years. | DOR is measured from the time measurement criteria are met for complete response (CR) or partial response (PR) (whichever is recorded first) until the first date that recurrent or progressive disease is objectively documented (taking as reference for progressive disease the smallest measurements recorded since the treatment started), death, or, in the absence of progressive disease (PD), date of last assessment. The response rate 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. Disease progression is \>20% increase in the sum of longest diameters of target lesions or appearance of a new lesion. |
| Other | Number of Participants With a Dose-limiting Toxicity (DLT) | First 28 days of treatment | 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) or avelumab 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. |
| Other | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 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. | Here is the number of participants with serious and/or non-serious adverse events assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0). A non-serious adverse event is any untoward medical occurrence. A serious adverse event is an adverse event or suspected adverse reaction that results in death, a life-threatening adverse drug experience, hospitalization, disruption of the ability to conduct normal life functions, congenital anomaly/birth defect or important medical events that jeopardize the patient or subject and may require medical or surgical intervention to prevent one of the previous outcomes mentioned. |
Source ClinicalTrials.gov
Outcomes9
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Maximum Tolerated Dose (MTD) of Interleukin 15 | First 28 days of treatment | mcg/kg | NUMBER | |
| SECONDARY | Mean Progression Free Survival (PFS) | 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. | Days | MEAN | |
| SECONDARY | Mean Event-free Survival (EFS) | 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. | Days | MEAN | |
| SECONDARY | Mean Overall Survival (OS) | 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. | Days | MEAN | |
| SECONDARY | Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells | From the time the subject began protocol treatment until end of treatment, progression or start of another therapy or approximately 2 years | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Number of Participants With Overall Best Response | 6 cycles (each cycle is 28 days) - approximately 168 days | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Mean Duration of Response (DOR) | From the time that response to therapy is first documented until progressive disease is observed or the subject is lost to follow-up or approximately 2 years. | Days | MEAN | |
| OTHER_PRE_SPECIFIED | Number of Participants With a Dose-limiting Toxicity (DLT) | First 28 days of treatment | Participants | COUNT_OF_PARTICIPANTS | |
| OTHER_PRE_SPECIFIED | Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | 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. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Maximum Tolerated Dose (MTD) of Interleukin 15 | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | NA | mcg/kg | ||
| Maximum Tolerated Dose (MTD) of Interleukin 15 | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | NA | mcg/kg | ||
| Mean Progression Free Survival (PFS) | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 303 | Standard Deviation 242 | Days | |
| Mean Progression Free Survival (PFS) | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 61.5 | Standard Deviation 55.9 | Days | |
| Mean Event-free Survival (EFS) | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 176 | Standard Deviation 140 | Days | |
| Mean Event-free Survival (EFS) | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 33.54 | Standard Deviation 0.98 | Days | |
| Mean Overall Survival (OS) | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 529 | Standard Deviation 345 | Days | |
| Mean Overall Survival (OS) | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 300 | Standard Deviation 430 | Days | |
| Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | Partial Response | 2 | Participants | |
| Overall Response in Participants With Greater Than or Equal to 50% Programmed Death-ligand 1 (PD-L1) Expressing Tumor Cells | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | Partial Response | 0 | Participants |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Dose Escalation | STARTED | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 6 | |
| Dose Escalation | STARTED | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 2 | |
| Dose Escalation | COMPLETED | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 1 | |
| Dose Escalation | COMPLETED | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | |
| Dose Escalation | NOT COMPLETED | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 5 | |
| Dose Escalation | NOT COMPLETED | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 2 | |
| Dose Expansion | STARTED | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | |
| Dose Expansion | STARTED | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | |
| Dose Expansion | COMPLETED | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | |
| Dose Expansion | COMPLETED | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events114
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 | Agitation | Psychiatric disorders | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 1 | 6 | 1 |
| other | Agitation | Psychiatric disorders | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | 2 | 0 |
| other | Alkaline phosphatase increased | Investigations | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | 6 | 0 |
| other | Alkaline phosphatase increased | Investigations | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 2 | 2 | 2 |
| other | Anemia | Blood and lymphatic system disorders | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 2 | 6 | 6 |
| other | Anemia | Blood and lymphatic system disorders | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | 2 | 0 |
| other | Anorexia | Metabolism and nutrition disorders | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 1 | 6 | 1 |
| other | Anorexia | Metabolism and nutrition disorders | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | 2 | 0 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 1 | 6 | 1 |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | 2 | 0 |
1 to 10 of 114Source ClinicalTrials.gov
See all 114 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 3 | 6 |
| Total, all-cause mortality | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | 2 |
| Total, other adverse events | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 3 | 6 |
| Total, other adverse events | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 2 | 2 |
| Total, serious adverse events | Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab | 6 | 6 |
| Total, serious adverse events | Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab | 0 | 2 |
Source ClinicalTrials.gov
Papers2
The papers the trial lists on ClinicalTrials.gov.
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab vs Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab: Number of Participants With a Dose-limiting Toxicity (DLT) | Trial comparisons |
Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab vs Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab: Number of Participants With Serious and/or Non-serious Adverse Events Assessed by the Common Terminology Criteria for Adverse Events (CTCAE v5.0) | Trial comparisons |
| Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab vs Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab: deaths from any cause | Trial comparisons |
| Dose Escalation - Dose Level 1, 1mcg/kg Interleukin-15 With 10 mg Avelumab vs Dose Level 2, 2mcg/kg Interleukin-15 With 10 mg Avelumab: serious adverse events | Trial comparisons |
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/NCT03905135
GET https://conductscience.org/api/trials/v1/NCT03905135/results?page=2