Study of REGN6569 and Cemiplimab in Adult Patients With Advanced Solid Tumor Malignancies

Browse trials for

• Squamous Cell Carcinoma of Head and Neck 1,711
• Neoplasm Metastasis 3,562

Keywords

• Unselected solid tumors dose escalation
• HNSCC dose expansion
• Advanced stage solid tumor malignancy
• Unresectable
• Metastatic

Squamous Cell Carcinoma of Head and Neck

1,711 studies on the registry are indexed under Squamous Cell Carcinoma of Head and Neck; 544 are open to participants now.

This study's enrollment of 38 is below the median of 50 across 1,456 interventional studies indexed under Squamous Cell Carcinoma of Head and Neck.

Lead sponsor

Regeneron Pharmaceuticals is the lead sponsor of 409 studies on the registry; 92 are open to participants now.

Of its 123 completed or terminated interventional studies of FDA-regulated products, 79 (64%) have results posted.

Eligibility criteria

Study arms

• Experimental
  Dose Escalation

  REGN6569 lead-in, then combo therapy

  Drug: REGN6569 · Drug: Cemiplimab

• Experimental
  Dose Expansion

  Randomized 1:1 between cohorts Cohort 1: Concurrent start of REGN6569 + cemiplimab Cohort 2: REGN6569 lead-in, then combo therapy

  Drug: REGN6569 · Drug: Cemiplimab

Interventions

• DrugREGN6569

  Administered by intravenous (IV) infusion

• DrugCemiplimab

  Administered by IV infusion

  Also known as: REGN2810, Libtayo

Primary outcomes

1. Incidence of dose-limited toxicities (DLTs)

   Dose escalation period

   Time frame: Up to 42 days

2. Incidence and severity of treatment emergent adverse events(TEAEs)

   Dose escalation period

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

3. Incidence and severity of adverse events of special interest (AESIs)

   Dose escalation period

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

4. Incidence and severity of serious adverse events (SAEs)

   Dose escalation period

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

5. Incidence and severity of grade ≥3 laboratory abnormalities

   Dose escalation period

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

6. Objective response rate (ORR)

   Dose expansion period

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

7. Characterize percentage change in intratumoral glucocorticoid-induced tumor necrosis factor receptor-Related (GITR)+ Treg density

   Dose expansion period

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

Secondary outcomes

1. ORR

   Dose escalation period

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

2. Disease control rate (DCR)

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

3. Duration of Response (DOR)

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

4. Progression-free Survival (PFS)

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

5. Overall survival (OS)

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

6. Drug concentrations of REGN6569 in serum

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

7. Drug concentrations of cemiplimab in serum

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

8. Immunogenicity as measured by anti-drug antibodies (ADA) to REGN6569

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

9. Immunogenicity as measured by anti-drug antibodies (ADA) to cemiplimab

   Dose escalation and expansion periods

   Time frame: Up to 90 days after the last dose of REGN6569 and/or cemiplimab, whichever is administered last, an average of approximately 30 months

Individual participant data

Plan to share: Yes — All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report, Analytic code

Time frame: When Regeneron has: received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry) the legal authority to share the data, and ensured the ability to protect participant privacy

Access criteria: Qualified researchers may request access to anonymized patient level data or aggregate study data when Regeneron has received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency [EMA], Pharmaceuticals and Medical Devices Agency [PMDA], etc) for the product and indication, has the legal authority to share the data, and has made the study results publicly available (eg, scientific publication, scientific conference, clinical trial registry).

Data sharing details ↗ · vivli.org