PHASE 1B/2 STUDY OF ITU V937 IN COMBINATION WITH PEMBROLIZUMAB

Not Applicable

• Conditions: -C97 Malignant neoplasms of independent (primary) multiple sites; Malignant neoplasms of independent (primary) multiple sites; C97

• Registration Number: PER-066-20
• Lead Sponsor: Merck Sharp & Dohme Corp., una subsidiaria de Merck & Co. Inc.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-10-22
• Study Completion: 2022-02-07
• Last Update Posted: 13 November 2023

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 2

Inclusion Criteria

1. Has locally-advanced disease that is not amenable to surgery or radiation, or Stage IV advanced/metastatic solid tumor malignancies
2. Has histologically- or cytologically-confirmed diagnosis of an advanced/metastatic solid
tumor
3. Has measurable disease by RECIST 1.1 criteria as assessed by investigator. Target lesions in a previously irradiated area will be considered measurable if progression has been demonstrated in such lesions
4. Has submitted a baseline tumor sample for analysis (either de novo biopsy or an archival tumor block).
5. Has a performance status of 0 or 1 on the ECOG Performance Scale obtained within 72 hours prior to the first dose of study intervention
6. If participants have known HIV-positive disease, participants must have well-controlled HIV on ART
7. Demonstrate adequate organ function as defined in Table 7 (Refer to the Protocol)
8. Is male or female, from ≥18 years of age inclusive, at the time of signing the informed consent
9. Male participants are eligible to participate if they agree to the following during the intervention period for and for at least 120 days after the last dose of study intervention (Refer to the Protocol)
10. A female participant is eligible to participate if she is not pregnant or breastfeeding, and at least one of the following conditions applies (Refer to the Protocol)
11. The participant (or legally acceptable representative) provides written informed consent for the study. The participant may also provide consent for future biomedical research. However, the participant may participate in the main study without participating in future biomedical research
12. Arm 1: Have at least one injectable lesion amenable to injection and/or biopsy.
13. Cohort A: Has locally recurrent, inoperable OR metastatic breast cancer treated with no more than 2 prior lines of therapy with skin involvement and/or subcutaneous lesions or accessible lymph nodes amenable to local injection
14. Cohort A: Has diagnosis of triple-negative breast cancer (estrogen receptor, progesterone receptor, and HER2-receptor negative status).
15. Cohort A: Has been treated with (neo)adjuvant anthracycline (unless anthracycline was contraindicated based on treating physician’s medical judgment)
16. Cohort B: Has histologically confirmed advanced or metastatic HNSCC of the oral cavity, oropharynx, hypopharynx, and/or larynx considered incurable and/or treated with no more than 1 previous line of therapy
17. Cohort B: Tumors must be PD-L1+ (CPS ≥1%)
18. Cohort B: Has documentation of HPV status for oropharyngeal cancers only. If HPV status has been previously determined, no retesting is required
19. Cohort C: Has histologically confirmed cSCC as the primary site of malignancy (metastatic skin involvement from another primary cancer or from cancers of unknown primary are not eligible).
20. Cohort C: Recurrent/metastatic disease only: Has metastatic disease defined as disseminated disease distant from the initial/primary site of diagnosis and/or with a history of locally-recurrent disease previously treated with surgery and/or radiotherapy, which is now incurable
21. Cohort C: Locally-advanced disease only: Participants ineligible for surgical resection. Contraindications to surgery are defined as:
22. Cohort C: Locally-advanced disease only: Received prior XRT to the index site or deemed ineligibl

Exclusion Criteria

1. Has had chemotherapy, definitive radiation, or biological cancer therapy within 4 weeks (2 weeks for palliative radiation) prior to first dose of study intervention, or has not recovered to CTCAE Grade 1 or better
2. If major or minor surgery was performed at/near the area being considered for injection, participant must be recovered from toxicity and/or complications of intervention.
3. Has had injection, or radiation therapy of >30 Gy, participant must be recovered from toxicity and/or complications of intervention.
4. Has a history of second malignancy, unless potentially curative treatment has been completed with no further evidence of malignancy
5. Has known active CNS metastases and/or carcinomatous meningitis. Participants with treated brain metastases may participate if lesions are radiologically stable.
6. Has an active infection requiring therapy (exceptions: HIV criteria outlined in Section 5.1.1 and HBV and HCV criteria for HCC cohort as stated in Section 5.1.4.1 of the protocol)
7. Has a history of interstitial lung dis
8. Has a history of noninfectious pneumonitis requiring active steroid therapy or ongoing pneumonitis
9.Has an active autoimmune disease that required systemic treatment in the past 2 years (ie, necessitating use of disease modifying agents, corticosteroids, or immunosuppressive drugs) except vitiligo or resolved childhood asthma/atopy. Replacement therapy such as thyroxine, insulin, or physiologic corticosteroid replacement therapy (steroid use ≤10 mg prednisone, or its equivalent, daily) is not considered a form of systemic treatment and is allowed. The use of non-systemic steroids is permitted
10.Participants with known Hepatitis B or C infections or known to be positive for HBsAg/HBV DNA or Hepatitis C Antibody or RNA. Active Hepatitis C is defined by a known positive Hep C Ab result and known quantitative HCV RNA results greater than the lower limits of detection of the assay.
11.Participants with a history of Kaposi’s sarcoma and/or Multicentric Castleman’s Disease.
12.Has known hypersensitivity to V937 and/or pembrolizumab or any of their excipients
13.Has known psychiatric or substance abuse disorder that significantly interferes with cooperation with requirements of the trial
14.Has received prior therapy with anti-PD-1/PD-L1 agents, T-VEC or any other oncolytic virus therapies
15.Has received a live vaccine within 30 days prior to first dose of study drug. Examples of live vaccines include, but are not limited to: measles, mumps, rubella, varicella/zoster (chicken pox), yellow fever, rabies, BCG, and typhoid vaccine. Seasonal influenza vaccines for injection are generally killed virus vaccines and are permitted. However, intranasal influenza (eg, FluMist®) and OPV vaccines are live attenuated vaccines and not permitted
16.Is currently participating in or has participated in a study of an investigational agent or has used an investigational device within 4 weeks prior to the first dose of study intervention
17.Is pregnant or breastfeeding or expecting to conceive or father children within the projected duration of the study, starting with the screening visit through 120 days after the last dose of study intervention
18.Has had esophageal or gastric variceal bleeding within the last 6 months. All participants should undergo screening for esophageal varices, unless such screening has been performed in t

Study & Design

• Study Type: Interventional
• Study Design: Not specified