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Ph Ib/II TAK-981 + Pembrolizumab Combination in Patients w/ Select Advanced or Met Solid Tumors

Krishnansu Tewari


A Study On:

  • Cervix

Status:

Eligibility

18 Years and older (Adult, Older Adult)

Interested in joining this trial?

Official Title

A Phase Ib/II Study of TAK-981 Plus Pembrolizumab to Evaluate the Safety, Tolerability, and Antitumor Activity of the Combination in Patients with Select Advanced or Metastatic Solid Tumors

Details

The purpose of this study is to determine the safety and tolerability of TAK-981 in combination with pembrolizumab in participants with select solid tumor indications and to establish the recommended phase 2 dose (RP2D) during Phase 1b of study and to evaluate the preliminary efficacy of TAK-981 at the RP2D in combination with pembrolizumab in participants with select solid tumor indications in Phase 2 of the study.


Eligibility

You can join if...

Inclusion Criteria:

-Has a histologically or cytologically documented, advanced (metastatic and/or unresectable) cancer
-Has at least 1 radiologically measurable lesion
-Has left ventricular ejection fraction (LVEF) greater than or equal to 40%; as measured by echocardiogram (ECHO) or multiple-gated acquisition (MUGA) scan.
-Has recovered to Grade 1 or baseline from all toxicity associated with previous therapy or have the toxicity established as sequela.
Note: Has a neuropathy less than or equal to Grade 2, any grade alopecia, or autoimmune endocrinopathies with stable replacement therapy are permitted.
-Demonstrate adequate organ function as determined by laboratory values

Exclusion Criteria:
-Has received extended field radiotherapy in less than or equal to 4 weeks before the start of treatment (less than or equal to7 days for limited field radiation for palliation outside the chest or brain).
-Has a history of uncontrolled brain metastasis
-Second malignancy within the previous 3 years
-Has a history of immune-related adverse events (AEs) related to treatment with immune CPIs that required treatment discontinuation.
-Is receiving or requires the continued use of medications that are known to be strong or moderate inhibitors and inducers of cytochrome P-450 (CYP) 3A4/5.
-Had received any live vaccine (e.g., varicella, pneumococcus) within 4 weeks of initiation of study treatment.
-Has a history of autoimmune disease requiring systemic immunosuppressive therapy with daily doses of prednisone >10 mg/day or equivalent doses, or any other form of immunosuppressive therapy. Hormone therapy (e.g., thyroxine, insulin, or physiologic corticosteroid replacement therapy for adrenal or pituitary insufficiency) is not considered an excluded form of systemic treatment of an autoimmune disease.
-Has a history of noninfectious pneumonitis that required steroids or a history of interstitial lung disease.
-Has a evidence of active, non-infectious pneumonitis.
-Has a history of allogeneic tissue or solid organ transplant.
-Has a active infection requiring systemic therapy.
-Has a known history of HIV infection or any other relevant congenital or acquired immunodeficiency.
-Has a known hepatitis B virus surface antigen seropositive or detectable hepatitis C infection viral load. Note: Participants who have positive hepatitis B core antibody or hepatitis B surface antigen antibody can be enrolled but must have an undetectable hepatitis B viral load.

Get in touch with our study team