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MEDI5752 in Patients With Mature Tertiary Lymphoid Structures Solid Tumors.

ConditionAdvanced Solid Tumor
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorInstitut Bergonié

About this trial

Multicentric, prospective, multi-indication, single-treatment arm, open-label phase II trial assessing the efficacy of MEDI5752

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Histologically confirmed solid tumor

IO-naïve patients (cohort A) OR patients with secondary resistance to PD1/PDL1 inhibitors (cohort B),

have to be diagnosed previously treated with PD-L1/PD-1 inhibitors (investigational or approved),

must have experienced initial clinical benefit (stable disease or better) from checkpoint inhibitor therapy for at least 4 months in which there was at least one interval scan prior to 4 months demonstrating no progression of disease.

Disqualifiers

Any anticancer treatment within 21 days or 5 half-lives (whichever is shorter) prior to start of study treatment,

Whole brain radiotherapy within 14 days prior to start of study treatment,

Radiotherapy treatment to more than 30% of the bone marrow or with a wide field of radiation within 4 weeks of the first dose of study drug.

Stereotactic radiosurgery within 7 days prior to start of study treatment,

Trial design

Design model

Parallel

Treatments tested in this trial

  • MEDI5752

    Drug

    A treatment cycle consists of 3 weeks. MEDI5752 will be administered by intravenous infusion at a fixed dose on Day 1 of each cycle

Treatment groups

102 Participants
are divided into 2 treatment groups
Group A: Cohort A: patients with TLS+ IO-naïve solid tumorsExperimental treatment 1 intervention
Group B: Cohort B: patients with TLS+ PD1/PDL1-experienced solid tumorsExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of the antitumor activity of MEDI5752 (independently for eah cohort)

Antitumor activity will be assessed in terms of objective response rate within 24 weeks based on RECIST v1.1, independently for each cohort, and based on centralized radiological review. Objective response under treatment is defined as patients with confirmed complete response or confirmed partial response, as per RECIST v1.1, observed during treatment with the investigational product. Objective response rate is defined as the proportion of patients alive with objective response based on RECIST v1.1. Objective response is recorded from study treatment initiation until the end of treatment.

Time frame
an expected average of 6 months

Secondary outcomes

1

24-weeks clinical benefit rate (CBR) independently for each cohort

CBR is defined as the proportion of patients with clinical benefit at 6 months. Clinical benefit is defined as confirmed complete response, confirmed partial response or stable disease more than 24 weeks, defined as per RECIST v1.1.

Time frame
24 weeks
2

Best overall response (BoR) independently for each cohort

BoR is defined as the best response recorded from the start of the study treatment until the end of treatment taking into account any requirement for confirmation. The best overall response is determined once all the data for the participant is known (RECIST v1.1).

Time frame
Throughout the treatment period, an expected average of 6 months
3

Duration of response (DoR) independently for each cohort

DoR is defined as the time from documentation of tumor response (complete response/partial response whichever is first recorded) to disease progression, according to RECIST v1.1. DoR will be assessed in responder (confirmed CR / PR) patients only.

Time frame
Throughout the treatment period, an expected average of 6 months
4

1-year progression-free survival (PFS), independently for each cohort

PFS is defined as the time from study treatment initiation to the first occurrence of disease progression or death (of any cause), whichever occurs first

Time frame
1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Institut Bergonié

Lead sponsor

National Cancer Institute, France

Collaborator

AstraZeneca

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: