Pulsed Dose Chemotherapy Plus Pembrolizumab in Recurrent/Metastatic HNSCC

Conditions

• Recurrent/Metastatic Head and Neck Squamous Cell Carcinoma (R/M HNSCC)

Eligibility Criteria

Sex

ALL

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Pembrolizumab — DRUG
  Immunotherapy that works by helping the immune system to kill cancer cells by targeting and blocking a protein called PD-1 on the surface of certain immune cells called T-cells. Blocking PD-1 triggers the T-cells to find and kill cancer cells.
• Carboplatin — DRUG
  A chemotherapy drug that contains the metal platinum. It stops or slows the growth of cancer cells and other rapidly growing cells by damaging their DNA.
• Paclitaxel — DRUG
  A chemotherapeutic agent used as a treatment for various cancers; paclitaxel is a mitotic inhibitor.

Study Details

The rationale for the new sequence of pulsed dose chemotherapy proposed in this trial is based on the hypotheses that current standard dosing of chemotherapy plus pembrolizumab ultimately suppresses the immune system and has a negative effect on the efficacy of the anti-PD-1 monoclonal antibody (mAb) therapy and that chemotherapy given after anti-PD-1 mAb therapy is associated with higher efficacy.

Key Dates

Start date

Oct 3, 2023

Status verified

Feb 2026

Primary completion

Dec 31, 2026

Completion

Dec 31, 2027

Study Design

Enrollment

15 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Pembrolizumab + Carboplatin with Paclitaxel
  Pembrolizumab: Administer 200 mg intravenously (IV) every 3 weeks (q3w); maintenance will be continued at 400 mg IV q6w for 12 cycles for a total of 2 years of therapy Carboplatin: Started with cycle 2 (C2) of pembrolizumab and continued thereafter every 3rd cycle of pembrolizumab for a total of 4 cycles with paclitaxel; carboplatin will be given at C2, C5, C8, and C11 of pembrolizumab. Paclitaxel: Started with cycle 2 (C2) of pembrolizumab and continued thereafter every 3rd cycle of pembrolizumab for a total of 4 cycles with carboplatin.

Primary Outcome Measure

6-month Progression-free Survival (PFS) [ Time Frame: At 6 months ]

Central Contacts

• Jennifer Ruth, RN, BSN
  412-623-8963
  [email protected]

Locations (1)

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