MPDL3280A-treatment-IST-UMCG

NCT02478099 | Active Not Recruiting Phase 2

• 1 other identifier: ML29755
• Study Type: interventional
• Target: 81
• Locations: 1 country
• Sites: 1

Brief Summary

To be able to evaluate the investigational imaging - 89Zr-MPDL3280A-PET, 89Zr-CD8 imaging and 18F-FB-IL2-PET - as complementary tools for selection of patients to be treated with MPDL3280A, within this treatment trial the investigators will assess safety, tolerability and anti-tumor activity of MPDL3280A in cancer patients, who have undergone investigational imaging.

Conditions

Locally Advanced or Metastatic Solid Tumors

Keywords

MPDL3280A; solid tumors

Outcome Measures

Primary Outcomes (1)

• Evaluation of efficacy of MPDL3280A after investigational imaging as measured by objective response rate

  2 years

Secondary Outcomes (10)

• To evaluate progression free survival (PFS) according to standard RECIST v1.1 as assessed by the investigator.

  2 years

• To evaluate duration of response (DOR) according to standard RECIST v1.1 as assessed by the investigator.

  2 years

• To evaluate DOR according to modified RECIST as assessed by the investigator.

  2 years

• To evaluate ORR according to modified RECIST as assessed by the investigator.

  2 years

• To evaluate PFS according to modified RECIST as assessed by the investigator.

  2 years

Study Arms (1)

1 Treatment with MPDL3280A

EXPERIMENTAL

Treatment with MPDL3280A

Drug: MPDL3280A

Interventions

MPDL3280A DRUG

Anti-PD-L1 antibody

1 Treatment with MPDL3280A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically or cytologically documented locally advanced or metastatic solid tumor, whom in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti PD-L1 immunotherapy .
• Participation within the 18F-IL2 imaging trial (IL2-img-UMCG-2015) or 89Zr-MPDL3280A antibody imaging trial (MPDL3280A-img-042015) or CD8 imaging trial (ZED88082-img-UMCG-2018) before participation in the MPDL3280A treatment trial.
• Subject must have undergone a fresh tumor biopsy for PD-L1 assessment performed as part of one of the investigational imaging trials.
• Subjects are eligible if disease progression during or following first-line chemotherapy or any subsequent treatment lines for locally advanced or metastatic solid tumor whom, in the opinion of the investigator, based on available clinical data, may benefit from treatment with anti PD-L1 immunotherapy .
• ● Additional criteria for cancer of the urinary tract:
• Subjects with disease progression during or following platinum-based adjuvant/neoadjuvant chemotherapy are eligible if ≤ 12 months have elapsed between the last treatment administration and the date of recurrence.
• ● Additional criteria for NSCLC:
• Subjects with disease progression during or following platinum-based adjuvant/neoadjuvant chemotherapy or concurrent chemoradiation for NSCLC are eligible if ≤ 6 months have elapsed between the last treatment administration and the date of recurrence.
• Subjects with a known sensitizing mutation in the epidermal growth factor receptor (EGFR) gene must also have experienced disease progression (during or after treatment) or intolerance to treatment with erlotinib, gefitinib, or another EGFR tyrosine kinase inhibitor (TKI).
• Subjects with a known Anaplastic Lymphoma Kinase (ALK) fusion oncogene must also have experienced disease progression (during or after treatment) or intolerance to treatment with crizotinib or another ALK inhibitor.
• Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
• Life expectancy ≥12 weeks.
• Signed Informed Consent Form.
• Ability to comply with protocol.
• Age ≥18 years.

You may not qualify if:

• Any approved anti-cancer therapy, including chemotherapy or hormonal therapy within ≤21 days prior to the first full dose of MPDL3280A; the following exceptions are allowed:
• Hormone-replacement therapy or oral contraceptives.
• TKIs approved for treatment of NSCLC discontinued \>7 days prior to the first full dose of MPDL3280A. The baseline scan must be obtained after discontinuation of prior TKIs.
• Treatment with any other investigational agent, other than the investigational tracer 89Zr-MPDL3280A, 18F-FB-IL2 or 89Zr-CD8-imaging, or participation in another clinical trial with therapeutic intent within 28 days prior to the first full dose of MPDL3280A.
• Unstable brain metastases.
• Unstable leptomeningeal disease.
• Uncontrolled tumor-related pain.
• Subjects requiring pain medication must be on a stable regimen at study entry.
• Symptomatic lesions amenable to palliative radiotherapy (e.g., bone metastases or metastases causing nerve impingement) should be treated prior to enrollment. Subjects should be recovered from the effects of radiation. There is no required minimum recovery period.
• Asymptomatic metastatic lesions whose further growth would likely cause functional deficits or intractable pain (e.g., epidural metastasis that is not currently associated with spinal cord compression) should be considered for loco-regional therapy if appropriate prior to enrollment.
• Uncontrolled pleural effusion, pericardial effusion, or ascites requiring recurrent drainage procedures (once monthly or more frequently). Subjects with indwelling catheters (e.g., PleurX) are allowed.
• Uncontrolled hypercalcemia (\> 1.5 mmol/L ionized calcium or calcium \>12 mg/dL or corrected serum calcium \>ULN) or symptomatic hypercalcemia requiring continued use of bisphosphonate therapy or denosumab.
• Subjects, who are receiving bisphosphonate therapy or denosumab specifically to prevent skeletal events and who do not have a history of clinically significant hypercalcemia are eligible.A second malignancy within 5 years prior to Cycle 1 Day 1, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome (such as adequately treated carcinoma in situ of the cervix, basal or squamous cell skin cancer, localized prostate cancer treated with curative intent, ductal carcinoma in situ treated surgically with curative intent).
• Pregnant and lactating women.
• History of severe allergic, anaphylactic, or other hypersensitivity reactions to chimeric or humanized antibodies or fusion proteins.

Sponsors & Collaborators

• University Medical Center Groningen: lead

Study Sites (1)

University Medical Center Groningen

Groningen, 9713 GZ, Netherlands

Location

Related Publications (1)

• Bensch F, van der Veen EL, Lub-de Hooge MN, Jorritsma-Smit A, Boellaard R, Kok IC, Oosting SF, Schroder CP, Hiltermann TJN, van der Wekken AJ, Groen HJM, Kwee TC, Elias SG, Gietema JA, Bohorquez SS, de Crespigny A, Williams SP, Mancao C, Brouwers AH, Fine BM, de Vries EGE. 89Zr-atezolizumab imaging as a non-invasive approach to assess clinical response to PD-L1 blockade in cancer. Nat Med. 2018 Dec;24(12):1852-1858. doi: 10.1038/s41591-018-0255-8. Epub 2018 Nov 26.

  PMID: 30478423 DERIVED

MeSH Terms

Interventions

atezolizumab

Study Officials

• Elisabeth de Vries, Professor

  University Medical Center Groningen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 21, 2015
• First Posted: June 23, 2015
• Study Start: February 24, 2016
• Primary Completion: September 19, 2023
• Study Completion: July 1, 2024
• Last Updated: May 3, 2024

Record last verified: 2024-05

Locations

NL (1)