Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer (MOUNTAINEER-02)

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Seagen

Status and phase

Active, not recruiting
Phase 3
Phase 2

Conditions

Esophageal Adenocarcinoma
Gastroesophageal Junction Adenocarcinoma
Gastric Adenocarcinoma

Treatments

Drug: paclitaxel
Drug: trastuzumab
Other: trastuzumab placebo
Other: tucatinib placebo
Drug: tucatinib
Drug: ramucirumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT04499924
SGNTUC-022

Details and patient eligibility

About

This study is being done to see if tucatinib with trastuzumab, ramucirumab and paclitaxel works better than ramucirumab and paclitaxel to treat HER2-positive (HER2+) cancer of the gut (stomach or gastroesophageal cancer). This study will also look at what side effects happen when participants take this combination of drugs. A side effect is anything the drug does other than treating cancer. Study treatment will be given in 28-day cycles. In the Phase 2 part of the trial, participants and their doctors will know what drugs are being given (open-label). In the Phase 3 part, the study is "blinded." This means that participants, their doctor, and the study sponsor will not know which drugs are being given.

Enrollment

17 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Histologically or cytologically confirmed diagnosis of locally-advanced unresectable or metastatic HER2+ gastric or gastroesophageal junction adenocarcinoma (GEC)

HER2+ disease documented since progression of the most recent line of systemic therapy, as follows:

Phase 2 paclitaxel dose optimization stage:

  • HER2 amplification in a blood-based NGS assay performed at a central laboratory, or
  • HER2 overexpression/amplification immunohistochemistry (IHC) and in situ hybridization (ISH) (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample

Phase 2 dose expansion stage:

  • Cohort 2A: HER2 amplification in a blood-based NGS assay performed at a central laboratory
  • Cohort 2B: No HER2 amplification by blood-based NGS assay, but HER2 overexpression/amplification by IHC and ISH (IHC3+ or IHC2+/ISH+) assay of a tumor tissue sample
  • Phase 3: HER2 amplification in a blood-based NGS assay performed at a central laboratory
  • History of prior treatment with a HER2-directed antibody
  • Progressive disease during or after first-line therapy for locally-advanced unresectable or metastatic GEC
  • Phase 2: Measurable disease according to RECIST version 1.1
  • Phase 3: Measurable or non-measurable disease according to RECIST version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
  • Life expectancy of at least 3 months, in the opinion of the investigator

Exclusion criteria

  • Subjects with squamous cell or undifferentiated GEC
  • Having received more than 1 line of prior systemic therapy for locally-advanced unresectable or metastatic disease
  • Having received taxanes ≤12 months prior to enrollment, prior treatment with ramucirumab, or prior treatment with tucatinib, lapatinib, neratinib, afatinib, or any other investigational anti-HER2 and/or anti-EGFR tyrosine kinase inhibitor, or with T-DM1, T-Dxd, or any other HER2-directed antibody-drug conjugate
  • Phase 2 paclitaxel dose optimization stage only: history of prior partial or total gastrectomy
  • Unable to swallow pills

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

17 participants in 4 patient groups

Phase 2 Arm
Experimental group
Description:
Tucatinib + trastuzumab + ramucirumab + paclitaxel
Treatment:
Drug: ramucirumab
Drug: tucatinib
Drug: trastuzumab
Drug: paclitaxel
Arm 3A
Experimental group
Description:
Tucatinib + trastuzumab + ramucirumab + paclitaxel
Treatment:
Drug: ramucirumab
Drug: tucatinib
Drug: trastuzumab
Drug: paclitaxel
Arm 3B
Active Comparator group
Description:
Ramucirumab + paclitaxel + tucatinib placebo + trastuzumab placebo
Treatment:
Drug: ramucirumab
Other: tucatinib placebo
Other: trastuzumab placebo
Drug: paclitaxel
Arm 3C
Experimental group
Description:
Tucatinib + ramucirumab + paclitaxel + trastuzumab placebo
Treatment:
Drug: ramucirumab
Drug: tucatinib
Other: trastuzumab placebo
Drug: paclitaxel

Trial contacts and locations

48

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Data sourced from clinicaltrials.gov

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