Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.
Inclusion Criteria:
Arm-1: Advanced ER-positive and HER2-negative Breast Cancer
1. Signed, written, voluntary, and informed consent
2. Histological confirmation of advanced ER positive and HER2 negative breast cancer
3. Fresh frozen tumor DNA sequencing has been completed by selected NGS vendor(s) at the
time of or prior to treatment initiation
4. Female participants between 18 - 85 years of age
5. ECOG performance status that is equal to 0 or 1 at the time of screening.
6. Must be willing to provide blood for immune profile analysis on study enrollment and
at specified study time points
7. Must be willing and able to perform stool sample collection
8. Participants due to receive first-line therapy with palbociclib and letrozole or
palbociclib and fulvestrant
Arm-2: Advanced Melanoma
1. Signed, written, voluntary, and informed consent
2. Histological or cytological confirmation of unresectable Stage III or unresectable
Stage IV melanoma
3. Fresh frozen tumor DNA sequencing has been completed by selected NGS vendor(s) at the
time of or prior to treatment initiation
4. Adults aged between 18 and 85 years old
5. ECOG performance status that is equal to 0 or 1 at the time of screening
6. Participants due to receive first-line systemic treatment with PD-1 checkpoint
inhibitor therapy
7. Must be willing to provide blood for immune profile analysis
8. Must be willing and able to perform stool sample collection
Exclusion Criteria:
Arm-1: Advanced ER-positive and HER2-negative Breast Cancer
1. Adult males
2. Mental incapacity, as determined by an investigator
3. Participant is pregnant, breastfeeding, or plans to become pregnant during the course
of the study
4. Experiencing active brain metastasis/metastases
5. Active participation in an immuno-oncology or interventional clinical trial
6. Participation in any experimental trial in the 3 months prior to screening
7. Participant has relapsed on prior endocrine therapy for this instance of cancer, or
has discontinued any prior adjuvant endocrine therapy within 6 months of screening
8. History of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes, or
significant prior bowel resection as judged by the study investigator
9. Use of immunosuppressants, including steroids, within 4 weeks of the first sample
collection
10. Oral or intravenous antibiotic usage within 3 months of the first sample collection
Arm-2: Advanced Melanoma
1. Diagnosis of uveal or mucosal melanoma
2. Mental incapacity, as determined by an investigator
3. Participant is pregnant, breastfeeding, or plans to become pregnant during the course
of the study
4. Experiencing active brain metastasis/metastases
5. Active participation in an immuno-oncology or interventional clinical trial
6. Participation in any experimental trial in the 3 months prior to screening
7. History of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes, or
significant prior bowel resection as judged by the study investigator
8. Use of immunosuppressants, including steroids, within 4 weeks of the first sample
collection
9. Oral or intravenous antibiotic usage within 3 months of the first sample collection
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility last updated 1/30/24. Questions regarding updates should be directed to the study team contact.