Trial Outcomes & Findings for Localized Radiation Therapy or Recombinant Interferon Beta and Avelumab With or Without Cellular Adoptive Immunotherapy in Treating Patients With Metastatic Merkel Cell Carcinoma (NCT NCT02584829)

Last Updated: 2022-03-22

Results Overview

Median time to new metastases reported for each group below. Group 1 result is NA, patient had no new detectable metastases in study follow-up period. Arm I is not analyzed because the one patient in Arm I did not experience new metastasis in their followup period, so they are not evaluable.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Up to 1 year

Results posted on

2022-03-22

Participant Flow

Participant milestones

Participant milestones
Measure	Group 1 (Avelumab and MHC Class I Up-regulation) Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Overall Study STARTED	1	7
Overall Study COMPLETED	0	3
Overall Study NOT COMPLETED	1	4

Reasons for withdrawal

Reasons for withdrawal
Measure	Group 1 (Avelumab and MHC Class I Up-regulation) Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Overall Study Physician Decision	1	0
Overall Study Withdrawal by Subject	0	1
Overall Study Progressive Disease	0	3

Baseline Characteristics

Localized Radiation Therapy or Recombinant Interferon Beta and Avelumab With or Without Cellular Adoptive Immunotherapy in Treating Patients With Metastatic Merkel Cell Carcinoma

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 1 year

Population: Patient in group 1 did not experience new metastasis in followup period of 1 year. Only 4 patients in group 2 experienced new metastases in the followup period of 1 year. The other 3 patients in group 2 were omitted due to no new metastases.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=4 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Evidence of Response, Based on Median Time to New Metastasis	53 Days Standard Deviation 23.45	—

PRIMARY outcome

Timeframe: Up to 4 weeks after the last infusion

Evidence and nature of toxicity related to the treatment will be assessed and compared between groups.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=1 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Count of Participants Who Experienced Adverse Events, Evaluated According to the Current Guidelines in National Cancer Institute (NCI) Common Toxicity Criteria Version 4.0	1 Participants	6 Participants

SECONDARY outcome

Timeframe: 28 days post infusion

Patients were evaluated for their disease response throughout their follow up period. Disease response reported is best response per patient. A complete response (CR) will be defined as total regression of all tumors, a PR as 30% or greater decrease in the sum of the longest diameter of target lesions compared to baseline and PD as 20% increase in the sum of the longest diameter of target lesions compared to the smallest prior diameter (RECIST v1.1 criteria).

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=1 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Disease Response, as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 Complete Response	1 Participants	2 Participants
Disease Response, as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 Partial Response	0 Participants	1 Participants
Disease Response, as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 Stable Disease	0 Participants	0 Participants
Disease Response, as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 Progressive Disease	0 Participants	3 Participants
Disease Response, as Assessed by Response Evaluation Criteria in Solid Tumors Version 1.1 Partial Complete Response	0 Participants	1 Participants

SECONDARY outcome

Timeframe: Up to 3 months

Quantiﬁcation of the overall recognition of the MCPyV T-antigen for each patient will likely be performed by testing the reactivity of whole peripheral blood mononuclear cells (PBMC) before and at indicated timepoints after treatment to peptides 15 amino acids (aa) in length offset by 5 aa bases spanning the whole T-antigen protein to include both CD8 and CD4 responses regardless of the HLA type of the patient. Due to changes in assay technology, epitope spreading was detected using a flow cytometric based intracellular cytokine assay.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Count of Participants That Displayed Evidence of Epitope Spreading	2 Participants	—

SECONDARY outcome

Timeframe: Up to 3 months

To evaluate the direct ex vivo function of the transferred cells, where possible, tetramer+ cells within collected peripheral blood mononuclear cells (PBMCs) will be evaluated for production of intracellular cytokines including interferon (IFN), tumor necrosis factor alpha and interleukin-2 in response to cognate antigen using an intracellular cytokine assay. This endpoint was evaluable in 4 of 7 patients, all 4 of whom upregulated interferon, tumor necrosis factor alpha and IL-2 expression in response to cognate antigen using intracellular cytokine assay. Persistence was not detected for 3 out of 7 patients in group 2, making them unevaluable for functional capacity.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=4 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Functional Capacity of Transferred T Cells (Group 2)	4 Participants	—

SECONDARY outcome

Timeframe: Up to 1 year

Survival status in patients with Merkel cell carcinoma will be evaluated. Data is reported as count of participants that survived past the 1 year follow up period.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=1 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Merkel Cell Carcinoma (MCC)-Specific Survival	1 Participants	6 Participants

SECONDARY outcome

Timeframe: Up to 90 days post infusion

Persistence of trasferred T cells was evaluated and assessed after 90 days. Patients were counted if transferred T cells were detected beyond 90 days.

Outcome measures

Outcome measures
Measure	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Count of Participants Who Displayed Persistence of Transferred T Cells in Blood and Tumor (Group Co2)	4 Participants	—

Adverse Events

Group 1 (Avelumab and MHC Class I Up-regulation)

Serious events: 1 serious events

Other events: 1 other events

Deaths: 0 deaths

Group 2 (Avelumab, MHC Class I Up-regulation, T Cells)

Serious events: 0 serious events

Other events: 6 other events

Deaths: 3 deaths

Serious adverse events

Serious adverse events
Measure	Group 1 (Avelumab and MHC Class I Up-regulation) n=1 participants at risk Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 participants at risk Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci	0.00% 0/7 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci

Other adverse events

Other adverse events
Measure	Group 1 (Avelumab and MHC Class I Up-regulation) n=1 participants at risk Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 participants at risk Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection
Investigations Lymphocyte count decreased	100.0% 1/1 • Number of events 1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci	57.1% 4/7 • Number of events 8 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci
General disorders Fever	0.00% 0/1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci	14.3% 1/7 • Number of events 1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci
Vascular disorders Hypertension	0.00% 0/1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci	14.3% 1/7 • Number of events 1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci
Infections and infestations Skin infection	0.00% 0/1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci	14.3% 1/7 • Number of events 1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci
Skin and subcutaneous tissue disorders Skin ulceration	0.00% 0/1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci	14.3% 1/7 • Number of events 1 • Up to 12 months after infusion All unexpected and serious AEs which may be due to study treatment or intervention must be reported to the FHCRC Institutional Review Office (IRO) per their current reporting requirements. All grade ≥ 3 CTCAE v.4 AEs will be collected through 4 weeks after each participant's last T-cell infusion and per section 12.C. Beginning 4 weeks after the participant's last infusion, only study related toxicities will be collected.ci

Additional Information

Dr. Aude Chapuis

Fred Hutchinson Cancer Research Center

Phone: 2066674369

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Group 1 (Avelumab and MHC Class I Up-regulation) n=1 Participants Patients who do not have a HLA type for which T cells can be generated or for whom T cells cannot be generated for technical issues receive avelumab intravenously (IV) over 1 hour every 2 weeks for 12 months. Within 7-10 days after completion of 1-3 doses of avelumab, patients receive MHC class I up-regulation intervention comprising either localized radiation therapy or recombinant interferon beta via intra-tumor injection. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Group 2 (Avelumab, MHC Class I Up-regulation, T Cells) n=7 Participants Patients who have an HLA type for which T cells can be generated receive avelumab IV over 1 hour every 2 weeks for 12 months. Patients also receive MHC class I up-regulation intervention as in Group 1 between 7-10 days after the first infusion of avelumab and 2-5 days before the first infusion of MCPyV TAg-specific polyclonal autologous CD8+ T cells. Patients receive two infusions of MCPyV TAg-specific polyclonal autologous CD8+ T cells IV over 60-120 minutes. Avelumab: Given IV Laboratory Biomarker Analysis: Correlative studies MCPyV TAg-specific Polyclonal Autologous CD8-positive T Cells: Given IV Radiation Therapy: Undergo radiation therapy Recombinant Interferon Beta: Given via intra-tumor injection	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=5 Participants	7 Participants n=7 Participants	7 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Sex: Female, Male Female	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	1 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	7 Participants n=7 Participants	8 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	1 participants n=5 Participants	7 participants n=7 Participants	8 participants n=5 Participants