A Phase 1/2 Trial of MK-1308 in Subjects with Advanced Solid Tumors

Phase 1

• Conditions: Advanced Solid Tumors - first-line, advanced/metastatic NSCLC and second-line (and beyond) advanced/metastatic SCLC and Melanoma; MedDRA version: 21.1Level: PTClassification code 10059514Term: Small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10059515Term: Non-small cell lung cancer metastaticSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025671Term: Malignant melanoma stage IVSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10025670Term: Malignant melanoma stage IIISystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2019-003703-35-IT
• Lead Sponsor: MERCK SHARP & DOHME CORP. UNA SUSSIDIARIA DI MERCK & CO. INC.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2021-06-14
• Last Update Posted: 30 August 2021

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 412

Inclusion Criteria

Male and female participants who are at least 18 years of age on the day of signing consent will be enrolled.
1) For Dose Escalation Phase: Have any histologically- or cytologicallyconfirmed advanced/metastatic solid tumor (except NSCLC for Cohorts 2 and 3) by pathology report and have received, been intolerant to, been ineligible for or refused all treatment
known to confer clinical benefit.
2) For Dose Confirmation Phase, Arms A, B, C, E: Have newly diagnosed histologically or cytologically-confirmed stage IIIB/stage IV NSCLC:
3) For Dose Confirmation Phase, Arm D: Have histologically- or cytologically confirmed metastatic (Stage III/IV) SCLC with progressive disease after at least one platinumbased chemotherapy regimen.
4) Have measurable disease by RECIST 1.1 as assessed by the local site investigator/radiology.
5) Have a performance status of 0 or 1 on ECOG Performance Scale.
6) Demonstrate adequate organ function. All screening labs should be performed within the screening period.
7) female participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:
• Is not a WOCBP
OR
- Is a WOCBP and using a contraceptive method that is highly effective, with low user dependency, or be abstinent from heterosexual intercourse as their preferred and usual lifestyle during the intervention period and for at least 120 days after the last dose of pembrolizumab or MK-1308A, whichever comes last. A WOCBP must have a negative highly sensitive pregnancy test (urine or serum as required by local regulations) within 24 hours for urine and within 72 hours for serum before the first dose of study intervention.
[...] 12) For Efficacy Expansion Phase Arms F, G and J: [...]

For the remaining inclusion criteria refer to protocol
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 206
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 206

Exclusion Criteria

1) For all phases of the study: Has received previous treatment with another agent targeting CTLA4.
2) For Dose Confirmation Phase and arm L only: Has received previous treatment with another agent targeting PD-1, PD-L1, or anti-PD-L2 agent or with an agent directed to another stimulatory or co-inhibitory T-cell receptor (eg, OX-40, CD137).
3) Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to the first dose of study therapy, or has not recovered to CTCAE Grade 1 or better from any adverse events that were due to cancer therapeutics administered more than 4 weeks earlier.
4) Has received lung radiation therapy of >30 Gy within 6 months before the first dose of study treatment.
5) Is currently participating and receiving study therapy in a study of an investigational agent or has participated and received study therapy in a study of an investigational agent or has used an investigational device within 28 days of administration of MK-1308.
6) Has history of a second malignancy, unless potentially curative treatment has been completed with no evidence of malignancy for 3 years.
7) For Cohorts 1-3,Arms A through E, and arm L ONLY: Has known untreated central nervous system (ie, brain and/or spinal cord) metastases. Has known carcinomatous meningitis.
8) Has received any prior immunotherapy and was discontinued from that treatment due to a Grade 3 or higher irAE.
9) Previously had a severe hypersensitivity reaction to treatment with a monoclonal antibody or has a known sensitivity to any component of pembrolizumab.
10) Has any active infection requiring therapy.
11) Has a history of interstitial lung disease.
12) Has a history of (non-infectious) pneumonitis that required steroids or current pneumonitis.

For the remaining exclusion criteria refer to the protocol

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified