Health TrialsbyHealthPanel

Pan-tumor Neoadjuvant Basket Study of Immune Check-point Inhibition and Novel Immuno-oncology Combinations

ConditionsResectable MMR-deficient Solid TumorsResectable MMR-proficient Solid Tumors
Trial statusRecruiting
Trial phasePhase 2, Phase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorThe Netherlands Cancer Institute

About this trial

In this study, the efficacy of botensilimab and balstilimab in mismatch repair deficient (dMMR) and mismatch repair proficient (pMMR) tumors will be assessed.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Signed written informed consent

Patients at least 18 years of age

Non-metastatic, newly diagnosed dMMR and pMMR cancers either fitting within a specific basket or in the "other" cohort (e.g. sarcoma, head and neck cancers, anal cancer, esophageal SCC)

In case of pMMR tumors: no indication for neoadjuvant therapy according to standard of care, unless adjuvant treatment is considered a standard of care alternative;

Disqualifiers

Signs of distant metastases on imaging and physical examination

Clinical obstruction

Clinical symptoms or radiological suspicion of perforation

Previous treatment with immune checkpoint inhibitors including but not limited to anti-CTLA4 or anti-PD1

Trial design

Design model

Parallel

Treatments tested in this trial

  • botensilimab

    Drug

    Anti cytotoxic T-lymphocyte associated protein-4 (anti-CTLA4)

  • balstilimab

    Drug

    Anti programmed cell death protein-1 (anti-PD1)

  • FLOT (Fluorouracil+Leucovorin+Oxaliplatin+Docetaxel)

    Drug

    5-Fluorouracil (2400mg/m2), leucovorin (200mg/m2), oxaliplatin (85mg/m2), docetaxel (50mg/m2).

Treatment groups

133 Participants
are divided into 11 treatment groups

11

Treatment groups

See each treatment group below.

Group A: Cohort 2: pMMR Safety run-in 1 - closed (accrual reached)Experimental treatment 2 interventions
Group B: Cohort 4: pMMR Safety run-in 2 - closed (accrual reached)Experimental treatment 2 interventions
Group C: Cohort 1: dMMR Safety run-in 1 - closed (accrual reached)Experimental treatment 2 interventions
Group D: Cohort 3: dMMR Safety run-in 2 - closed (accrual reached)Experimental treatment 2 interventions
Group E: Cohort 6: dMMR Colorectal basket - closed (accrual reached)Experimental treatment 2 interventions
Group F: Cohort 5: dMMR Upper gastro-intestinal cancer basketExperimental treatment 2 interventions
Group G: Cohort 7: dMMR "other cancers" basketExperimental treatment 2 interventions
Group H: Cohort 8: pMMR TNBC cohortExperimental treatment 2 interventions
Group I: Cohort 9: pMMR "other cancers" - cohort closedExperimental treatment 2 interventions
Group J: Cohort 10: pMMR GEA basketExperimental treatment 3 interventions
Group K: Cohort 11: dMMR Rectal Organ Preservation basketExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

1

Major pathological response rate

Percentage of patients in which a major pathologic response (MPR) is reported, defined as \<10% residual viable tumor (RVT) in the resection specimen.

Time frame
Week 8

Secondary outcomes

1

Pathological response rates

Pathologic complete response (pCR) defined as no RVT in the primary tumor and locoregional lymph nodes; partial pathologic response (≤50% RVT) and no pathologic response (\>50% RVT)

Time frame
Week 8
2

Event free survival

Event-free survival defined as time from registration to the date of disease progression, local, regional or distant recurrence, occurrence of a second primary cancer or death from any cause.

Time frame
3 years
3

Disease free survival

Disease free survival defined as the time from surgery to disease recurrence during follow-up which consists of either local or regional recurrence, metastatic disease or disease-related death.

Time frame
3 years
4

Overall survival

Overall survival defined as time from registration until death from any cause.

Time frame
5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

The Netherlands Cancer Institute

Lead sponsor

Agenus Inc.

Collaborator

Source ClinicalTrials.gov
Apply now