A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors
NCT ID: NCT03530397
Last Updated: 2024-06-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE1
401 participants
INTERVENTIONAL
2018-04-24
2025-12-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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Arm A: MEDI5752
MEDI5752
MEDI5752
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
Arm B: MEDI5752 and chemotherapy
MEDI5752, pemetrexed, carboplatin and paclitaxel.
MEDI5752
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
Pemetrexed
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Carboplatin
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Paclitaxel or Nab-Paclitaxel
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Arm C: Pembrolizumab and chemotherapy
pembrolizumab, pemetrexed, and carboplatin
Pemetrexed
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Carboplatin
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Pembrolizumab
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Interventions
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MEDI5752
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation.
Pemetrexed
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Carboplatin
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Pembrolizumab
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Paclitaxel or Nab-Paclitaxel
Subjects will remain on treatment until unacceptable toxicity, documentation of progressive disease, or development of other reason for treatment discontinuation
Eligibility Criteria
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Inclusion Criteria
2. World Health Organization/Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1 at enrollment
3. Life expectancy ≥ 12 weeks
4. Histologically or cytologically-confirmed advanced solid tumors
5. Subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4 therapy or any concurrent chemotherapy, radiotherapy, investigational, biologic, or hormonal therapy for cancer treatment may be eligible to enter the study following a washout period as applicable
6. Females of childbearing potential who are sexually active with a nonsterilized male partner must use at least one highly effective method of contraception
7. Nonsterilized males who are sexually active with a female partner of childbearing potential must use a male condom with spermicide where locally available from Day 1 and for 90 days after the final dose of investigational product. Males receiving pemetrexed or carboplatin must use contraception during study treatment and up to 6 months thereafter.
8. Subjects must have at least one measurable lesion
9. Adequate organ and marrow function
10. Written informed consent and any locally required authorization
11. Subjects must provide tumor material as applicable
Exclusion Criteria
2. Concurrent enrollment in another clinical study, unless it is an observational clinical study or the follow-up period of an interventional study
3. For subjects who have received prior anti-PD-1, anti-PD-L1, or anti-CTLA-4:
1. Subjects must not have received anti-PD-1, anti-PD-L1, anti-CTLA-4 or any other immunotherapy or immune-oncology (IO) agent within 21 days of commencing treatment with investigational product.
2. Subject must not have experienced a toxicity that led to permanent discontinuation of prior immunotherapy.
3. All AEs while receiving prior immunotherapy must have completely resolved or resolved to Grade 1 prior to screening for this study.
4. Current or prior use of immunosuppressive medication within 14 days before the first dose of investigational product is excluded.
5. Receipt of live attenuated vaccine within 30 days prior to the first dose of investigational product.
6. Active or prior documented autoimmune or inflammatory disorders
7. History of active primary immunodeficiency:
8. History of organ transplant
9. Known allergy or reaction to any component of the planned study treatment.
10. Untreated CNS metastatic disease, leptomeningeal disease, or cord compression
12. Major surgical procedure (as defined by the investigator) within 28 days prior to the first dose of Investigational Product or still recovering from prior surgery
13. Female subjects who are pregnant or breastfeeding, as well as male or female subjects of reproductive potential who are not willing to employ one highly effective method of birth control
14. Uncontrolled intercurrent illness, that would limit compliance with study requirement, substantially increase risk of incurring AEs or compromise the ability of the subject to give written informed consent.
15. Any condition that, in the opinion of the investigator, would interfere with evaluation of the investigational product or interpretation of the subject's safety or study results
16. Judgment by the investigator that the subject is unsuitable to participate in the study and the subject is unlikely to comply with study procedures, restrictions, and requirements.
18 Years
120 Years
ALL
No
Sponsors
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MedImmune LLC
INDUSTRY
Responsible Party
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Principal Investigators
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Deepa Subramaniam, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
AstraZeneca
Locations
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Research Site
Detroit, Michigan, United States
Research Site
New York, New York, United States
Research Site
Chapel Hill, North Carolina, United States
Research Site
Providence, Rhode Island, United States
Research Site
Chattanooga, Tennessee, United States
Research Site
Nashville, Tennessee, United States
Research Site
Fairfax, Virginia, United States
Research Site
Melbourne, , Australia
Research Site
Melbourne, , Australia
Research Site
Randwick, , Australia
Research Site
Bordeaux, , France
Research Site
Lyon, , France
Research Site
Villejuif, , France
Research Site
Meldola, , Italy
Research Site
Napoli, , Italy
Research Site
Ravenna, , Italy
Research Site
Roma, , Italy
Research Site
Amsterdam, , Netherlands
Research Site
Lisbon, , Portugal
Research Site
Porto, , Portugal
Research Site
Cheongju-si, , South Korea
Research Site
Gyeonggi-do, , South Korea
Research Site
Incheon, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
Seoul, , South Korea
Research Site
A Coruña, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Barcelona, , Spain
Research Site
Majadahonda, , Spain
Research Site
Málaga, , Spain
Research Site
Pamplona, , Spain
Research Site
Valencia, , Spain
Research Site
Taichung, , Taiwan
Research Site
Tainan City, , Taiwan
Research Site
Taipei, , Taiwan
Countries
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Other Identifiers
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2018-003075-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
D7980C00001
Identifier Type: -
Identifier Source: org_study_id
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