A Study to Evaluate MEDI5752 in Subjects With Advanced Solid Tumors (NCT03530397) — Spain Trial Details

Condition(s) studied

Selected Advanced Solid Tumors

Investigational drug(s) / intervention(s)

MEDI5752 →Pemetrexed →Carboplatin →Pembrolizumab →Paclitaxel or Nab-PaclitaxelAll Paclitaxel trials (424) →All Nab-paclitaxel trials (233) →

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

Study summary

The purpose of this study is to evaluate MEDI5752 and carboplatin and pemetrexed or paclitaxel or nab-paclitaxel in adult subjects with advanced solid tumors, when administered as a single agent or combined with chemotherapy.

Eligibility

Sex

ALL

Min age

18 Years

Max age

120 Years

Healthy volunteers

No

Inclusion Criteria 1. Age ≥ 18 years at the time of screening 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 1. Involvement in the planning and/or conduct of the study (applies to both MedImmune staff and/or staff at the study site) 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 11. Unresolved toxicities from prior anticancer therapy, defined as having not resolved to NCI CTCAE v4.03 Grade 0 or 1, or to levels dictated in the inclusion/exclusion criteria 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.

Primary outcome measure(s)

The number of subjects experiencing treatment related adverse events (AEs) (Dose-escalation phase) — From the time of informed consent through 114 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects experiencing adverse events (AEs) graded per NCI CTCAE v4.03
Preliminary anti-tumor activitiy of MEDI5752 (versus pembrolizumab, where applicable) using Objective Response based on RECIST v1.1 (Dose-expansion phase) — From the first dose of study drug through the date of first documented progression, end of study, date of death, or two years after the last patient starts treatment, whichever should occur first
The primary endpoint of antitumor activity include Objective Response and will be based on all post baseline disease assessments that occur prior to initiation of subsequent anticancer therapy.
The number of subjects experiencing dose-limiting toxicities (DLTs) (Dose-escalation phase) — Up to 21 days following the first dose
The primary endpoint is as assessed by the number of subjects experiencing dose limiting toxicities (DLTs) as defined by the protocol.
The number of subjects experiencing abnormal laboratory evaluations (Dose-escalation phase) — From the time of informed consent through 114 days following termination of treatment with investigational product
The primary endpoint is as assessed as the number of subjects experiencing changes in laboratory parameters from baseline.
The number of subjects experiencing changes from baseline in vital signs reported as adverse events (Dose-escalation phase) — From the time of informed consent through 114 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects experiencing clinically significant changes in vital signs from baseline.
The number of subjects experiencing abnormal electrocardiograms (ECG) reported as Adverse Events (Dose-escalation phase) — From the time of informed consent through 114 days following termination of treatment with investigational product
The primary endpoint is as assessed by the the number of subjects experiencing clinically significant changes in ECG parameters from baseline.
The number of subjects experiencing treatment related serious adverse events (SAEs) (Dose-escalation phase) — From the time of informed consent through 114 days following termination of treatment with investigational product
The primary endpoint is as assessed by the number of subjects with serious adverse events (SAEs) graded per NCI CTCAE v4.03.

Trial sites (40)

Facility	City	Region
Research Site	Detroit	Michigan
Research Site	New York	New York
Research Site	Chapel Hill	North Carolina
Research Site	Providence	Rhode Island
Research Site	Chattanooga	Tennessee
Research Site	Nashville	Tennessee
Research Site	Fairfax	Virginia
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	Naples	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	Taiwan
Research Site	Taipei	Taiwan

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