PhII Trial of Pembrolizumab in Advanced Solid Tumors

• Conditions: A-Anal Squamous Cell Carcinoma (CA)B-Biliary Adenocarcinoma (Gallbladder&Biliary Tree but excluding Ampulla of Vater Cancers)C-Neuroendocrine Tumors (well&moderately-differentiated,including Carcinoid)D-Endometrial CAE-Cervical Squamous Cell CAF-Vulvar Squamous Cell CAG-Small Cell Lung CAH-Malignant Pleural MesotheliomaI-Thyroid CA (Papillary or Follicular Subtype)J-Salivary Gland CA ORK-Other advanced solid tumor (except CRC) which is MSI-H from a newly obtained tumor biopsy; MedDRA version: 18.1Level: PTClassification code 10061045Term: Colon neoplasmSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2015-002067-41-ES
• Lead Sponsor: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-30
• Last Update Posted: 8 February 2016

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 520

Inclusion Criteria

1.Have a histologically or cytologically-documented, advanced (metastatic and/or unresectable) solid tumor that is incurable and for which prior standard first-line or later-line SOC treatments have failed. There is no limit to the number of prior treatment regimens.
2.Have one of the following advanced (unresectable and/or metastatic) tumor types:
(A)Anal Squamous Cell Carcinoma,
(B)Biliary Adenocarcinoma (Gallbladder and Biliary Tree but excluding Ampulla of Vater Cancers),
(C)Neuroendocrine Tumors (well- and moderately-differentiated, including Carcinoid),
(D)Endometrial Carcinoma (a)
(E)Cervical Squamous Cell Carcinoma,
(F)Vulvar Squamous Cell Carcinoma,
(G)Small Cell Lung Carcinoma,
(H)Mesothelioma (Malignant Pleural Mesothelioma),
(I)Thyroid Carcinoma (Papillary or Follicular Subtype),
(J)Salivary Gland Carcinoma (a)
OR
(K)Any other advanced solid tumor (except CRC), which is MSI-H from a newly obtained tumor biopsy.

(a)Note: All carcinoma subtypes are allowed; however, sarcomas or mesenchymal tumors are excluded.

3.Have submitted an evaluable tissue sample for biomarker analysis from a newly obtained core, incisional, or excisional biopsy of a tumor lesion not previously irradiated (exceptions may be considered after Sponsor consultation). Note: A newly obtained tumor specimen (i.e., collected since the completion of the most recent cancer therapy) for biomarker characterization will be required for enrollment of all subjects. Tissue from tumor progressing at a site of prior radiation may be allowed for biomarker characterization, based on the Sponsor?s approval.
4.If enrollment in Groups A-J has moved to biomarker enrichment, have a tumor that is positive for one or more of the pre-specified primary biomarker(s), as assessed by the central laboratory. These enrichment biomarkers may be PD-L1 expression by IHC (at a percentage to be prespecified), a positive tumor RNA GEP score (at a prespecified cut-off), and/or tumor MSI-H.
5.Have radiologically measurable disease based on RECIST 1.1. Independent central radiologic review must confirm the presence of radiologically measureable disease based on RECIST 1.1 for the subject to be eligible to participate in the trial (see Site Procedure Manual for detailed instructions). Tumor lesions situated in a previously irradiated area are considered measurable if progression has been demonstrated in such lesions.

Refer to protocol for complete list
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 260
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 260

Exclusion Criteria

-Has a diagnosis of immunodeficiency or is receiving systemic steroid therapy or any other form of immunosuppressive therapy within 7 days prior to the first dose of trial treatment. The use of physiologic doses of corticosteroids may be approved after consultation with the Sponsor.
-Has an active autoimmune disease that has required systemic treatment in the past 2 years (i.e., with use of disease modifying agents, corticosteroids or immunosuppressive drugs). Replacement therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered a form of systemic treatment.
-Has had a prior anti-cancer monoclonal antibody (mAb) within 4 weeks prior to study Day 1 or who has not recovered (i.e., < or = to Grade 1 or at baseline) from AEs due to mAbs administered more than 4 weeks earlier.
-Has had prior chemotherapy, targeted small molecule therapy, or radiation therapy within 2 weeks prior to study Day 1 or who has not recovered (i.e., < or = to Grade 1 or at baseline) from adverse events due to a previously administered agent.
Refer to protocol for complete list.

Study & Design

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