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Spartalizumab

Clinical trials with Spartalizumab are studying how this treatment performs in different cancers and patient groups. The trials focus on safety, tolerability, and signs of benefit such as disease control or survival. They include adults and, in one study, pediatric patients with hard-to-treat solid tumors.

Table of contents

Overview of Spartalizumab trials

These studies are looking at Spartalizumab in different cancer settings, often together with other cancer treatments.[1] The main goals are to learn about safety, tolerability, and whether the treatment may help control or slow cancer.[1]

The trial data include both interventional studies, meaning the researchers give a treatment and then measure the results, and different patient groups with advanced or hard-to-treat disease.[1][2]

Conditions being studied

One Phase 2 study is in patients with metastatic squamous cell anal carcinoma, which means anal cancer that has spread to other parts of the body.[1] Another Phase 2 study is in resectable gastric cancer, meaning stomach cancer that can still be removed with surgery.[2]

Other studies include people with different types of advanced cancer and people with refractory or recurrent solid tumors, which means solid tumors that do not respond well to treatment or come back after treatment.[3][5] One study also looked at patients with metastatic disease and high PD1 biomarker expression, but that trial used a different antibody and is not a Spartalizumab study in the trial title.[4]

Trial phases and what they mean

The Spartalizumab trials listed here are mainly Phase 1 and Phase 2 studies.[1][2][3][5]

Phase 1 trials are usually early studies that focus on safety, tolerability, and dose selection.[3][5] Phase 2 trials look more closely at whether the treatment seems to work in a specific cancer group, while still watching safety.[1][2]

Who can participate

Eligibility depends on the study and the cancer type being tested.[1][2][3] The trial data show adult patients with metastatic or advanced cancer, adults with resectable gastric cancer, and in one study both pediatric and adult patients with solid tumors that have returned or no longer respond to treatment.[3][5]

One trial is designed separately for a pediatric cohort and an adult cohort, so the goals are not the same for both age groups.[5] In the pediatric group, the study looks for the recommended dose for later testing, while in the adult group it looks at disease control at 6 months.[5]

Main endpoints being measured

The studies measure different endpoints, which are the main results researchers want to track.[1][2][3][5]

  • Progression-free survival (PFS) at 1 year in metastatic anal cancer: this means the number of patients alive without the cancer getting worse after 1 year.[1]

  • Pathologic complete response (pCR) in gastric cancer: this means no tumor is found in the tissue removed during surgery after pre-operative treatment.[2]

  • Adverse events and serious adverse events in the rollover safety study: these are unwanted medical problems that happen during treatment, including serious ones.[3]

  • Overall response rate (ORR) in the biomarker-selected metastatic disease study: this means the share of patients whose tumors shrink enough to count as a complete or partial response.[4]

  • Maximum tolerated dose (MTD) in the pediatric cohort of the SPARTO study: this is the highest dose that can be given without too many dose-limiting toxicities.[5]

  • Disease control rate at 6 months in the adult cohort of the SPARTO study: this includes complete response, partial response, or stable disease.[5]

Trial status and enrollment

The trial status is mixed. Some studies are authorised, some are completed, and one is suspended.[1][2][3][5]

Enrollment ranges from 34 patients in the anal cancer study to 184 patients in the biomarker-selected metastatic disease study.[1][4] This shows that the trials are looking at Spartalizumab in both smaller and larger patient groups.[1][4]

Trial ID Phase Condition studied Status Enrollment
2024-516005-23-00 Phase 2 Metastatic squamous cell anal carcinoma Authorised 34
NCT04736485 Phase 2 Resectable gastric cancer Completed 68
NCT04058756 Phase 1 Different types of advanced cancer Authorised 119
2023-508549-41-00 Phase 2 Metastatic disease with high PD1 biomarker expression Completed 184
NCT05210413 Phase 1 Refractory or recurrent solid tumor Suspended 74

FAQ

  • What is being studied in clinical trials with Spartalizumab? The trials study Spartalizumab alone or with other cancer treatments in different cancers, including metastatic anal cancer, resectable gastric cancer, and refractory or relapsed solid tumors. The main focus is on safety and how well the treatment works.
  • Who may take part in these trials? The target groups include adults with advanced or metastatic cancer, people with resectable gastric cancer, and in one study both pediatric and adult patients with solid tumors that have come back or no longer respond to treatment. Each trial has its own eligibility rules.
  • What trial phases are listed for Spartalizumab studies? The listed studies are Phase 1 and Phase 2 trials. Phase 1 studies mainly look at safety and dose finding, while Phase 2 studies look more closely at how well the treatment works.
  • What outcomes are the trials measuring? The trials measure outcomes such as progression-free survival, pathologic complete response, adverse events, overall response rate, maximum tolerated dose, and disease control rate. These show whether the treatment helps and how safe it is.
  • Are all of the Spartalizumab trials still active? No. The trial status varies. Some are authorised, some are completed, and one is suspended.

Igangværende kliniske forsøg for Spartalizumab

  • Test af kræftmedicin (spartalizumab og pazopanib) til behandling af tilbagevendende eller modstandsdygtige kræftknuder hos børn og voksne

    Rekrutterer endnu ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

  • Undersøgelse af ny behandling med spartalizumab og kemoterapi kombineret med strålebehandling til patienter med fremskreden analkræft

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Frankrig

  • Behandling før og efter operation af operabel mavekræft med spartalizumab i kombination med lægemidler (fluorouracil, leucovorin, oxaliplatin og docetaxel)

    Rekrutterer ikke

    1 1 1
    Undersøgte lægemidler:
    Frankrig

  • Undersøgelse af lægemidlet spartalizumab alene eller sammen med andre behandlinger hos patienter med fremskreden kræft – fokus på sikkerhed

    Rekrutterer ikke

    1 1 1
    Undersøgte sygdomme:
    Undersøgte lægemidler:
    Belgien Tjekkiet Frankrig Tyskland Ungarn Italien +2

  • Test af kræftmedicin (tislelizumab og spartalizumab) hos patienter med fremskreden kræft, hvor tumorer har høje PD1-niveauer

    Rekrutterer ikke

    1 1 1
    Undersøgte lægemidler:
    Spanien

Ordliste

  • Phase 1: An early trial phase that mainly checks safety, tolerability, and the best dose to use.
  • Phase 2: A trial phase that looks more closely at whether the treatment works in a certain cancer and continues to monitor safety.
  • Safety: How well a treatment can be used without causing unacceptable harm.
  • Tolerability: How well patients can handle a treatment and its side effects.
  • Progression-free survival (PFS): The length of time during and after treatment that a patient lives without the cancer getting worse.
  • RECIST: A standard way doctors use scans and measurements to see whether a tumor is shrinking, staying the same, or growing.
  • Overall response rate (ORR): The percentage of patients whose cancer shrinks enough to count as a complete or partial response.
  • Pathologic complete response (pCR): When no cancer is found in the tissue removed during surgery after treatment.
  • Disease control rate: The percentage of patients whose cancer is not getting worse, including complete response, partial response, or stable disease.
  • Maximum tolerated dose (MTD): The highest dose that can be given without causing too many serious side effects.
  • Dose-limiting toxicity (DLT): A side effect that is serious enough to limit how much of a treatment can be given.
  • Stable disease: When the cancer does not clearly shrink, but also does not clearly grow.

Referencer

  1. https://clinicaltrials.gov/study/2024-516005-23-00
  2. https://kliniske-forsoeg.dk/forsog/behandling-foer-og-efter-operation-af-operabel-mavekraeft-med-spartalizumab-i-kombination-med-laegemidler-fluorouracil-leucovorin-oxaliplatin-og-docetaxel/
  3. https://kliniske-forsoeg.dk/forsog/undersogelse-af-laegemidlet-spartalizumab-alene-eller-sammen-med-andre-behandlinger-hos-patienter-med-fremskreden-kraeft-fokus-pa-sikkerhed/
  4. https://clinicaltrials.gov/study/2023-508549-41-00
  5. https://kliniske-forsoeg.dk/forsog/test-af-kraeftmedicin-spartalizumab-og-pazopanib-til-behandling-af-tilbagevendende-eller-modstandsdygtige-kraeftknuder-hos-born-og-voksne/