Patient case: 74-year-old female with melanoma; genetic feature: no tumor infiltrating lymphocytes

Clinical trial: A Safety and Efficacy Extension Study of Pertuzumab in Patients With Solid Tumors Previously Enrolled in a Hoffmann-La Roche-Sponsored Pertuzumab Clinical Trial

Summary: This is a single-arm, multi-center, open-label extension study designed to provide pertuzumab to patients who continue to derive benefit from pertuzumab, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored Global study who continue to receive pertuzumab at the time of the Parent study end are eligible for continued treatment in this extension study. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the Investigator's opinion, may potentially benefit from continued Perjeta treatment will continue to receive pertuzumab until disease progression, unacceptable toxicities, Investigator decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor.


Eligibility: Inclusion Criteria:
  -  Informed consent
  -  Prior eligibility for, and receiving pertuzumab as an investigational medicinal product in, a Roche-sponsored study (either as a single agent or in combination with other anti-cancer drugs used in the Parent study) at the time of the Parent study closure
  -  Investigator's opinion that the patient continues to benefit from treatment
  Exclusion Criteria:
  -  Meets any of the exclusion criteria of the Parent protocol at the time the patient is considered for entry in the extension study
  -  Evidence of disease progression assessed according to Parent protocol before enrollment in to the extension study
  -  Permanent discontinuation of pertuzumab for any reason during the Parent study, or between the end of the Parent study and before enrollment into the extension study
  -  Any unresolved or irreversible toxicities during the Parent study that require permanent discontinuation of pertuzumab, according to Parent protocol or local label. Delay of treatment to wait for resolution of toxicities is allowed as long as it is within the guidelines of the respective Parent protocol and does not contradict exclusion criterion below.
  -  More than 9 weeks between the last dose of pertuzumab in the Parent study and the first dose pertuzumab in the extension study
  -  Left ventricular ejection fraction </= 50%
  -  Any serious uncontrolled concomitant disease that would contraindicate the use of pertuzumab or that would put the patient at high risk for treatment-related complications
  -  Treatment with any anti-cancer treatment (other than any treatment given as permitted in the Parent protocol) in the time period between last treatment in the Parent study and the first dose pertuzumab in the extension study (i.e. up to 9 weeks)
  -  Positive serum pregnancy test
  -  Women of child-bearing potential who are sexually active and do not agree to use a highly effective, non-hormonal form of contraception or two effective forms of non-hormonal contraception (such as barrier method in conjunction with spermicidal gel) during and for at least 6 months after the last dose or pertuzumab or 7 months after the last dose of trastuzumab or trastuzumab emtansine (T-DM1), if being used in combination
  -  Concurrent participation in any therapeutic clinical trial (other than the Parent study)
  -  Assessed by the Investigator to be unable or unwilling to comply with the requirements of the protocol

Relevance to patient case: not relevant