A phase 1-2 immunoPET imaging study with ZED88082A in patients before and during treatment with 1) MPDL3280A or 2) PD-1 antibody plus or minus ipilimumab
- Conditions
- Cancermetastases10027655
- Registration Number
- NL-OMON49728
- Lead Sponsor
- niversitair Medisch Centrum Groningen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
1. Subjects with histologically confirmed locally advanced or metastatic cancer
for the following tumor types
* Cancer types other than melanoma; subjects meeting the eligibility criteria
as formulated in the MPDL3280A treatment study protocol
(MPDL3280A-treatment-IST-UMCG) are eligible for part A or part B1.
* Melanoma; subjects eligible to receive standard of care anti-PD1 therapy plus
or minus ipilimumab, are eligible for part B2.
2. Tumor lesion(s) of which a histological biopsy can safely be obtained
according to standard clinical care procedures.
3. Measurable disease, as defined by standard RECIST v1.1. Previously
irradiated lesions should not be counted as target lesions.
4. Signed informed consent.
5. Age >=18 at the time of signing informed consent.
6. Life expectancy >=12 weeks.
7. Eastern Cooperative Oncology Group (ECOG) performance status 0-1
8. Ability to comply with the protocol.
9. For female patients of childbearing potential and male patients with
partners of childbearing potential, agreement (by patient and/or partner) to
use a highly effective form(s) of contraception (i.e., one that results in a
low failure rate [< 1% per year] when used consistently and correctly).
1. Potential subjects with cancer other than melanoma will be excluded from
participation in this study if they meet exclusion criteria formulated in the
MPDL3280A treatment study protocol (MPDL3280A-treatment-IST-UMCG).
2. Signs or symptoms of infection within 2 weeks prior to ZED88082A/CED88004S
injection.
3. Prior immune checkpoint inhibitor treatment, including but not limited to
anti-PD1 and anti-PD-L1 therapeutic antibodies.
4. History of severe allergic, anaphylactic, or other hypersensitivity
reactions to chimeric or humanized antibodies or fusion proteins
5. Any other diseases, metabolic dysfunction, physical examination finding, or
clinical laboratory finding giving reasonable suspicion of a disease or
condition that contraindicates the use of ZED88082A/CED88004S, or that may
affect the interpretation of the results or render the patient at high risk
from complications.
6. Pregnant or lactating women.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Assessment of safety of ZED88082A/CED88004S.<br /><br>Appropriate ZED88082A/CED88004S dosing and appropriate PET imaging<br /><br>time-points.<br /><br>Description of ZED88082A/CED88004S PK by measuring standardized uptake value<br /><br>(SUV) on the ZED88082A/CED88004S-PET scans 0, 2, 4 and/or 7 days after<br /><br>ZED88082A/CED88004S injection before and during immune checkpoint inhibitor<br /><br>treatment.<br /><br>Assessment of immunogenicity by ADA formation.</p><br>
- Secondary Outcome Measures
Name Time Method