Protocol Index	

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OP RESEARCH PRO00037722 ABDELRAHIM CA052002 PHASE1/2 SCREENING	

Types:      Research Oncology Treatment
Synonyms:  BMS-986340 , NIVOLUMAB, DOCETAXEL, SOLID TUMORS, ADVANCED, BRAIN, NECK, ABDOMEN, PELVIS , EXTREMITIES , PHASE 1/2, PRO00037722

Screening (-28 to -1)	Repeat 1 time	Cycle length: 1 day	Screening	Perform every 1 day x1		Procedures
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	a) Brain Imaging: MRI of the brain without and with contrast is required for participants with known or suspected brain metastases, unless participant has completed an imaging study of the brain within 28 days prior to date of first dose
 i) Required for NSCLC, SCCHN & Melanoma patients.
CT of the brain without and with contrast can be performed if MRI is contraindicated.
			Screening
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Biomarker Assessment

a) A fresh pre-treatment biopsy from a single, appropriately assessable lesion (obtained from a core biopsy, excisional biopsy, incisional or surgical specimen), is required for all participants.
Fine needle aspirates and other cytology specimens, bone lesions are not acceptable sites for biopsy.
For participants in Parts 2A and 2B, a repeat biopsy at screening or on-treatment from the same or an alternative site will be required if clinically
feasible (at the discretion of the investigator), and the initial attempt was unsuccessful in obtaining adequate
tissue for biomarker analysis. Only 1 repeat attempt may be performed at each time point, if clinically feasible.
 
An unsuccessful fresh tumor biopsy at screening or on-treatment will not exclude participants from receiving or
continuing study treatment.
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Biomarker Assessment 

b) Participants must have measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 and in addition have at least 1 lesion accessible for biopsy. 
1. Measureable: Tumor lesions: Must be accurately measured in at least one dimension (longest diameter in the
plane of measurement is to be recorded) with a minimum size of: 10 mm by CT/MRI scan (scan slice thickness no greater than 5 mm), or greater than or equal to 2x slice thickness If greater than 5mm.
2.Malignant lymph nodes: To be considered pathologically enlarged and measurable, a lymph node
must be 15 mm in short axis when assessed by CT/MRI scan (scan slice thickness recommended
to be no greater than 5 mm).
3. All other lesions are considered non-measurable, including small lesions (longest diameter
< 10mm or pathological lymph nodes with  10 to < 15 mm short axis) as well as truly
non-measurable lesions. Lesions considered truly non-measurable include: leptomeningeal
disease, inflammatory breast disease, lymphangitic involvement of skin or lung, abdominal
masses/abdominal organomegaly identified by physical exam that is not measurable by
reproducible imaging techniques.
 
Special considerations regarding lesion measurability:
Bone scan, PET scan and plain films are not considered adequate imaging techniques to
measure bone lesions. However, these techniques can be used to confirm the presence or
disappearance of bone lesions.
Lytic bone lesions or mixed lytic-blastic lesions, with identifiable soft tissue components, that can be evaluated by cross sectional imaging techniques such as CT or MRI can be considered as measurable lesions if the soft tissue component meets the definition of measurability described above.

Blastic bone lesions are non-measurable.
Note: Lesions on X-Ray are not to be selected as Target or Non-Target Lesions.
 
COLLECTION OF ARCHIVAL TUMOR TISSUE OPTIONAL: In addition to fresh tissue, archived tumor specimens, in the form of blocks or sectioned slides, are
optional and can be submitted prior to study treatment administration, if available.
Instructions for the collection and processing of all samples will be provided in the laboratory manual.

 
Instructions for the collection and processing of all samples will be provided in the laboratory manual.
			Nursing Orders
  	ONC NURSING COMMUNICATION 109	Interval: --	Occurrences: --	Comments:	Participants with MSS-CRC:
i) Participants must have received and then progressed on or after, or have been intolerant
or refractory to at least 1 standard systemic therapy for metastatic and/or unresectable
disease (or have progressed within 6 months of adjuvant therapy).
(1) Prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan given as a single
regimen or over multiple regimens is required.
(2) Prior treatment with an anti-angiogenic therapy (eg, bevacizumab) is required.
ii) Participants must have known MSI status or mismatch repair status.
(1) If the MSI molecular test and MMR IHC test results are both available, then both
MSS and MMR proficiency will be required for study entry. Patients with MSIhigh
or MSI-low or MMR deficiency will not be eligible.
iii) KRAS, NRAS and BRAF status, if known, should be documented.
(1) If RAS wild-type, prior treatment with an anti-EGFR therapy (eg, cetuximab or
panitumumab) is required
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Participants must have an Eastern Cooperative Oncology Group Performance Status of 0 or 1
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Participants must have experienced radiographically documented progressive disease on
or after the most recent therapy.
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Study participants will be expected to have received standard-of-care therapies (except for Part 1C, where participants with prior docetaxel use for the advanced/metastatic setting will be excluded), including an available PD-(L)1 inhibitor known to be effective in the tumor type for which they are being evaluated
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Participants must have advanced or metastatic disease and have received, be refractory to, not be a candidate for, or be intolerant to existing therapy(ies) known to provide clinical benefit for the condition of the participant.
		  	ONC NURSING COMMUNICATION 10	Interval: --	Occurrences: --	Comments:	Participants with NSCLC:
i) Histologically confirmed NSCLC meeting stage criteria for stage IIIB, stage IV, or
recurrent disease.
ii) Participants must have recurrent or progressive disease during or after platinum
doublet-based chemotherapy for advanced or metastatic disease, OR must have
recurrent or progressive disease within 6 months after completing platinum-based
chemotherapy for local disease
iii) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if
available.
iv) Status for actionable mutations (eg, epidermal growth factor [EGFR], anaplastic
lymphoma kinase [ALK], ROS oncogene 1 [ROS1], rearranged during transfection
[RET], etc.) must be known (when testing is available as per country/region standard
of care practices); participants with actionable mutations must have received and
progressed on, have been intolerant to, or not be a candidate for standard tyrosine
kinase inhibitors (as available per country/region standard-of-care practices).
		  	ONC NURSING COMMUNICATION 11	Interval: --	Occurrences: --	Comments:	Participants with SCCHN:
i) Participants must have histologically confirmed, recurrent, or metastatic SCCHN (oral
cavity, pharynx, larynx), and not amenable to local therapy with curative intent. Any
other cancers of the head and neck, including nasopharyngeal cancer, salivary gland,
and neuroendocrine tumors, are excluded.
ii) Participants must have progressed on or after, or been intolerant to a platinumcontaining
regimen.
iii) Prior curative radiation therapy must have been completed at least 4 weeks prior to first
study drug administration. Prior focal palliative radiotherapy must have been
completed at least 2 weeks before study drug administration.
iv) Historical human papillomavirus (HPV) status for oropharyngeal cancers must be
documented. HPV status should have been determined using p16
immunohistochemistry (IHC) or HPV polymerase chain reaction (PCR).
v) Participants must have received and progressed on or after anti-PD-(L)1 therapy, if
available.
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Participants with MSS-CRC:
i) Participants must have received and then progressed on or after, or have been intolerant
or refractory to at least 1 standard systemic therapy for metastatic and/or unresectable
disease (or have progressed within 6 months of adjuvant therapy).
(1) Prior treatment with fluoropyrimidine, oxaliplatin, and irinotecan given as a single
regimen or over multiple regimens is required.
(2) Prior treatment with an anti-angiogenic therapy (eg, bevacizumab) is required.
ii) Participants must have known MSI status or mismatch repair status.
(1) If the MSI molecular test and MMR IHC test results are both available, then both
MSS and MMR proficiency will be required for study entry. Patients with MSIhigh
or MSI-low or MMR deficiency will not be eligible.
iii) KRAS, NRAS and BRAF status, if known, should be documented.
(1) If RAS wild-type, prior treatment with an anti-EGFR therapy (eg, cetuximab or
panitumumab) is required
		  	ONC NURSING COMMUNICATION 100	Interval: --	Occurrences: --	Comments:	Participants with gastric/GEJ adenocarcinoma:
i) Participants must have received and then progressed, relapsed, or been intolerant to at
least 1 standard treatment regimen in the advanced or metastatic setting (or have
progressed within 6 months of adjuvant therapy).
ii) Participants with known human epidermal growth factor receptor 2 (HER2)-positive
gastric cancer must have received prior treatment with a HER2 inhibitor (eg,
trastuzumab).
iii) If available, MSI status or mismatch repair status should be documented.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Participants with cervical cancer (SCC or adenocarcinoma):
i) Must have received and then progressed, relapsed, or been intolerant to platinum-based
chemotherapy with or without bevacizumab in the advanced or metastatic setting.
ii) If available, MSI status or mismatch repair status should be documented.
		  	ONC NURSING COMMUNICATION 25	Interval: --	Occurrences: --	Comments:	Participants with renal cell carcinoma (RCC):
i) Participants must have histologically confirmed, recurrent, or metastatic RCC, and not
amenable to local therapy with curative intent.
ii) Participant had progression or refractory disease during or after at least 2 lines of
therapy, including a prior anti-PD-(L)1 therapy.
		  	ONC NURSING COMMUNICATION 117	Interval: --	Occurrences: --	Comments:	Participants with urothelial carcinoma (UC):
i) Participants must have histologically confirmed, recurrent, or metastatic UC, and not
amenable to local therapy with curative intent.
ii) Must have received and then progressed, relapsed, been intolerant to, or ineligible for
at least 1 platinum-containing chemotherapy regimen OR be within 12 months of perioperative
(neo-adjuvant or adjuvant) treatment with a platinum agent in the setting of
cystectomy for localized muscle-invasive UC.
iii) Must be resistant or refractory to anti-PD-(L)1-based immunotherapy.
		  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Participants with pancreatic adenocarcinomas (PDAC):
i) Participants must have histologically confirmed, recurrent, unresectable or metastatic
PDAC, and not amenable to local therapy with curative intent.
ii) Participants must have received and progressed or been intolerant to (or not be a
candidate for) at least 1 prior standard chemotherapy.
		  	ONC NURSING COMMUNICATION 4	Interval: --	Occurrences: --	Comments:	Participants with ovarian carcinomas (OC):
i) Participants must have histologically or cytologically confirmed, recurrent, or
metastatic epithelial ovarian cancer, primary peritoneal carcinoma or fallopian tube
cancer, and not amenable to local therapy with curative intent.
Participants must have received and then progressed, relapsed, or been intolerant to
platinum-based chemotherapy, OR must have recurrent or progressive disease within
6 months after completing platinum-based chemotherapy.
iii) Participants with BRCA1/2 mutation must have received treatment with a PARP
inhibitor, if available.
		  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	Participants with melanoma:
i) Participants must have cutaneous, acral, mucosal, or unknown primary melanoma.
Participants with uveal/ocular melanoma are not eligible.
ii) Participants must have histologically confirmed, recurrent, or metastatic melanoma,
and not amenable to local therapy with curative intent.
iii) Participants must have received and then progressed, relapsed, or been intolerant to at
least 1 standard treatment regimen in the advanced or metastatic setting, including a
prior anti-PD-(L)1 therapy, if available.
iv) Participants must have known BRAF status. If indicated, participants must have been
offered mutation-directed therapy that has proven survival benefit.
		  	ONC NURSING COMMUNCATION 101	Interval: --	Occurrences: --	Comments:	Participants with triple negative breast cancer (TNBC):
i) Participants must have histologically confirmed, recurrent, or metastatic TNBC, and
not amenable to local therapy with curative intent.
ii) Must have progression or refractory disease during or after at least 1 chemotherapy
regimen for the treatment of locally advanced or metastatic disease.
iii) Participants with BRCA1/2 mutation must have received treatment with a
platinum-containing regimen (if eligible) and a PARP inhibitor, if available.
iv) If PD-L1 positive (defined as combined positive score = 10), prior treatment with
immune checkpoint inhibitor is required.
			Screening
  	ONC NURSING COMMUNICATION 75	Interval: --	Occurrences: --	Comments:	Female participants:

Females, ages = 18 or local age of majority at the time of consent.
ii) Women who are not of childbearing potential are exempt from contraceptive
requirements.
iii) Women participants must have documented proof that they are not of childbearing
potential.
iv) Women of child bearing potential (WOCBP) must have a negative serum or urine pregnancy test (minimum sensitivity
25 IU/L or equivalent units of human chorionic gonadotropin [hCG]) within 24 hours
prior to the start of study treatment. An extension up to 72 hours prior to the start of
study treatment is permissible in situations where results cannot be obtained within the
standard 24-hour window.
v) WOCBP must agree to follow instructions for method(s) of contraception defined in
Appendix 4 and as described below and included in the ICF.
viii) WOCBP are permitted to use hormonal contraception methods (as described in
Appendix 4).
		  	ONC NURSING COMMUNICATION 80	Interval: --	Occurrences: --	Comments:	Male Participants: 

Males, age = 18 years or local age of majority at the time of consent.
ii) Male participants receiving BMS-986340 monotherapy and BMS-986340 in
combination with nivolumab require no specific contraceptive methods.
iii) Male participants receiving BMS-986340 in combination with docetaxel who are
sexually active with a WOCBP must agree to follow instructions for method(s) of
contraception described below:
(1) Male participants will be required to always use latex or other synthetic condom
during any sexual activity (eg, vaginal, anal, oral) with WOCBP, even if the
participants have undergone a successful vasectomy or if their partner is already
pregnant or breastfeeding. Males should continue to use a condom during the
intervention period and for at least 3 months after the last dose of study intervention.
(2) Female partners of males participating in the study should be advised to use highly
effective methods of contraception during the intervention period and for at least 3
months after the last dose of study intervention in the male participant.
(3) Male participants must refrain from donating sperm during the intervention period
and for at least 3 months after the last dose of study intervention.
(4) Breastfeeding partners should be advised to consult their health care providers
about using appropriate highly effective contraception during the time participant
is required to use condoms.
			Nursing Orders
  	ONC NURSING COMMUNICATION 2	Interval: --	Occurrences: --	Comments:	Obtain Informed Consent
		  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	IRT Participant Assignment
		  	ONC NURSING COMMUNICATION 8	Interval: --	Occurrences: --	Comments:	Inclusion/Exclusion criteria (Must be confirmed prior to first dose)
		  	ONC NURSING COMMUNICATION 6	Interval: --	Occurrences: --	Comments:	Medical History (All history relevant to disease under study including tobacco history, include all significant toxicities or allergies related to previous tx)
		  	ONC NURSING COMMUNICATION 9	Interval: --	Occurrences: --	Comments:	Prior Cancer Therapies (Including all prior cancer treatment regimens and medications administered)
		  	ONC NURSING COMMUNICATION 16	Interval: Until discontinued	Occurrences: --	Comments:	Physical Examination (if performed within 72 hours prior to dosing on Day 1 then single examination may count for screening and predose evaluation)
		  	ONC NURSING COMMUNICATION 14	Interval: --	Occurrences: --	Comments:	Assessment of signs & symptoms (within 14 days prior to dosing on Day 1)
		  	RESEARCH - HEIGHT AND WEIGHT	Interval: --	Occurrences: --		  	ONC NURSING COMMUNICATION 15	Interval: --	Occurrences: --	Comments:	ECOG Performance Status
		  	RESEARCH - VITAL SIGNS - T/P/R/BP	Interval: --	Occurrences: --	Comments:	Vital Signs (Body Temperature, Respiratory Rate, Seated/Supine Blood Pressure (obtained 5 minutes after rest), Heart Rate, Pulse oximetry)
		  	ONC NURSING COMMUNICATION 12	Interval: --	Occurrences: --	Comments:	Concomitant Medication Use (Within 14 days prior to dosing on Day 1) Vaccine use must be collected within 30 days prior to first dose
			Labs
☑	COMPREHENSIVE METABOLIC PANEL	Interval: --	Occurrences: --		☑	CBC WITH PLATELET AND DIFFERENTIAL	Interval: --	Occurrences: --		☑	MAGNESIUM LEVEL	Interval: --	Occurrences: --			Labs
  	AMYLASE LEVEL	Interval: --	Occurrences: --		  	LIPASE LEVEL	Interval: --	Occurrences: --		  	CREATINE KINASE, TOTAL (CPK)	Interval: --	Occurrences: --		  	C-REACTIVE PROTEIN	Interval: --	Occurrences: --		  	URIC ACID LEVEL	Interval: --	Occurrences: --		  	TROPONIN T 	Interval: --	Occurrences: --		  	GGT	Interval: --	Occurrences: --		  	PHOSPHORUS LEVEL	Interval: --	Occurrences: --		  	LDH	Interval: --	Occurrences: --		  	BILIRUBIN DIRECT	Interval: --	Occurrences: --		  	URINALYSIS, DIPSTICK ONLY (REFLEX TO MICROSCOPIC IF NEEDED)	Interval: --	Occurrences: --			Labs
  	THYROID STIMULATING HORMONE	Interval: --	Occurrences: --		  	T3	Interval: --	Occurrences: --		  	T4, FREE	Interval: --	Occurrences: --			Labs
  	HEPATITIS C ANTIBODY	Interval: --	Occurrences: --		  	HEPATITIS C VIRUS (HCV) RNA, DIAGNOSIS	Interval: --	Occurrences: --		  	HEPATITIS B SURFACE ANTIGEN	Interval: --	Occurrences: --		  	HEPATITIS B CORE ANTIBODY TOTAL	Interval: --	Occurrences: --		  	HEPATITIS B VIRUS (HBV), QUANTITATIVE PCR	Interval: --	Occurrences: --		  	HIV 1/2 ANTIGEN/ANTIBODY, FOURTH GENERATION, WITH REFLEXES	Interval: --	Occurrences: --			Labs
  	ONC NURSING COMMUNICATION 5	Interval: --	Occurrences: --	Comments:	Stool Sample will be collected for Parts 2A and 2B only
		  	ANTI-SARS-COV-2 TOTAL	Interval: --	Occurrences: --	Comments:	SARS-CoV-2 Viral Testing (RT-PCR or RAPID ANTIGEN) within 7 days prior to first dose of study treatment.
		  	FOLLICLE STIMULATING HORMONE	Interval: --	Occurrences: --	Comments:	screening - only required to confirm menopause in women age < 55
			Nursing Orders
  	ECG 12-LEAD	Interval: --	Occurrences: --	Comments:	Single reading
			Imaging
  	CT CHEST W CONTRAST ABDOMEN W CONTRAST PELVIS W CONTRAST	Interval: --	Occurrences: --	Comments:	ALL SUBJECTS, Add other known or suspected sites of disease if needed
			Nursing Orders
  	ONC NURSING COMMUNICATION 16	Interval: --	Occurrences: --	Comments:	CT/MRI of Neck 

Required only for SCCHN subjects.

Subjects with metastatic TNBC lesions outside of breast, MRI with contrasts of the breasts to be performed, RNs to enter order